Rule2023-09212
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications
Primary source
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Published
May 3, 2023
Effective
May 3, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (cNADAs) during January, February, and March 2023. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve their accuracy and readability.
Full Text
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<title>Federal Register, Volume 88 Issue 85 (Wednesday, May 3, 2023)</title>
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[Federal Register Volume 88, Number 85 (Wednesday, May 3, 2023)]
[Rules and Regulations]
[Pages 27693-27701]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-09212]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 516, 520, 522, 524, 526, 529, 556, and 558
[Docket No. FDA-2023-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs), abbreviated new animal drug
applications (ANADAs), and conditionally approved new animal drug
applications (cNADAs) during January, February, and March 2023. FDA is
informing the public of the availability of summaries of the basis of
approval and of environmental review documents, where applicable. The
animal drug regulations are also being amended to improve their
accuracy and readability.
DATES: This rule is effective May 3, 2023.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-5689,
<a href="/cdn-cgi/l/email-protection#0364666c7164662d6b626a61666f436567622d6b6b702d646c75"><span class="__cf_email__" data-cfemail="3453515b4653511a5c555d565158745250551a5c5c471a535b42">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Approvals
FDA is amending the animal drug regulations to reflect approval
actions for NADAs, ANADAs, and cNADAs during January, February, and
March 2023, as listed in table 1. In addition, FDA is informing the
public of the availability, where applicable, of documentation of
environmental review required under the National Environmental Policy
Act (NEPA) and, for actions requiring review of safety or effectiveness
data, summaries of the basis of approval (FOI Summaries) under the
Freedom of Information Act (FOIA). These public documents may be seen
in the office of the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. Persons
with access to the internet may obtain these documents at the CVM FOIA
Electronic Reading Room: <a href="https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room">https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room</a>. Marketing
exclusivity and patent information may be accessed in FDA's
publication, Approved Animal Drug Products Online (Green Book) at:
<a href="https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book">https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book</a>.
[[Page 27694]]
Table 1--Original and Supplemental NADAs, ANADAs, and cNADAs Approved During January, February, and March 2023 Requiring Evidence of Safety and/or
Effectiveness
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR
Approval date File No. Sponsor Product name Effect of the action Public documents section
--------------------------------------------------------------------------------------------------------------------------------------------------------
January 5, 2023................ 200-732 Felix Pharmaceuticals Carprofen Tablets Original approval for FOI Summary.............. 520.304
Pvt. Ltd., 25-28 (carprofen tablets) the relief of pain
North Wall Quay, Caplets. and inflammation
Dublin 1, Ireland. associated with
osteoarthritis and
for the control of
postoperative pain
associated with soft
tissue and orthopedic
surgeries in dogs as
a generic copy of
NADA 141-053.
January 11, 2023............... 200-611 Akorn Operating DETOMISED (detomidine Original approval as a FOI Summary.............. 522.536
Company LLC, 5605 hydrochloride) sedative and
Centerpoint Ct., Injectable Solution. analgesic to
Suite A, Gurnee, IL facilitate minor
60031. surgical and
diagnostic procedures
in horses as a
generic copy of NADA
140-862.
January 11, 2023............... 200-738 Aurora Pharmaceutical, DECTOGARD (doramectin Original approval for FOI Summary.............. 524.770
Inc., 1196 Highway 3 topical solution) treatment and control
South, Northfield, MN Topical Solution. of internal and
55057-3009. external parasites of
cattle as a generic
copy of NADA 141-095.
January 12, 2023............... 141-426 Intervet, Inc., 2 BRAVECTO (fluralaner) Supplemental approval FOI Summary.............. 520.998
Giralda Farms, Chewable tablets. for the treatment and
Madison, NJ 07940. control of Asian long
horned tick
infestations for 12
weeks in dogs and
puppies.
January 12, 2023............... 200-721 Norbrook Laboratories MIDAMOX for Cats Supplemental approval FOI Summary.............. 524.1146
Ltd., Carnbane (imidacloprid and for prevention of
Industrial Estate, moxidectin) Topical heartworm disease and
Newry, County Down, Solution. treatment of flea
BT35 6QQ, United infestations in
Kingdom. ferrets as a generic
copy of NADA 141-254.
January 12, 2023............... 200-733 Felix Pharmaceuticals Marbofloxacin Chewable Original approval for FOI Summary.............. 520.1310
Pvt. Ltd., 25-28 Tablets treatment of
North Wall Quay, (marbofloxacin). infections in dogs
Dublin 1, Ireland. and cats associated
with bacteria
susceptible to
marbofloxacin as a
generic copy of NADA
141-151.
January 12, 2023............... 200-734 Do.................... Praziquantel Tablets Original approval for FOI Summary.............. 520.1870
(praziquantel). removal or removal
and control of
certain canine
tapeworms as a
generic copy of NADA
111-798.
January 13, 2023............... 200-735 ZyVet Animal Health, Dexmedetomidine Original approval for FOI Summary.............. 522.558
Inc., 73 Route 31N, Hydrochloride use as a sedative,
Pennington, NJ 08534. (dexmedetomidine analgesic, and
hydrochloride) preanesthetic in dogs
Injectable Solution. and cats as a generic
copy of NADA 141-267.
January 13, 2023............... 200-736 Do.................... Marbofloxacin Tablets Original approval for FOI Summary.............. 520.1310
(marbofloxacin). treatment of
infections in dogs
and cats associated
with bacteria
susceptible to
marbofloxacin as a
generic copy of NADA
141-151.
February 2, 2023............... 200-737 Do.................... Enrofloxacin Original approval for FOI Summary.............. 520.812
(enrofloxacin) the management of
Flavored diseases associated
Antimicrobial Tablets. with bacteria
susceptible to
enrofloxacin in dogs
and cats as a generic
copy of NADA 140-441.
February 2, 2023............... 200-739 Do.................... Carprofen (carprofen) Original approval for FOI Summary.............. 520.304
Chewable Tablets. the relief of pain
and inflammation
associated with
osteoarthritis and
for the control of
postoperative pain
associated with soft
tissue and orthopedic
surgeries in dogs as
a generic copy of
NADA 141-111.
February 9, 2023............... 200-701 Chanelle PARASEDGE Multi for Supplemental approval FOI Summary.............. 524.1146
Pharmaceuticals Cats (imidacloprid for prevention of
Manufacturing Ltd., and moxidectin) heartworm disease and
Loughrea, County Topical Solution. treatment of flea
Galway, Ireland. infestations in
ferrets as a generic
copy of NADA 141-254.
[[Page 27695]]
February 24, 2023.............. 200-741 Aurora Pharmaceutical, EPRIGARD Original approval for FOI Summary.............. 524.814
Inc., 1196 Highway 3 (eprinomectin) treatment and control
South, Northfield, MN Topical Solution. of internal and
55057-3009. external parasites in
cattle as a generic
copy of NADA 141-079.
March 21, 2023................. 200-743 Provetica LLC, 8735 MODULIS for Dogs Original approval for FOI Summary.............. 520.522
Rosehill Rd., Suite (cyclosporine oral the control of atopic
300, Lenexa, KS 66215. solution) USP dermatitis in dogs as
MODIFIED. a generic copy of
NADA 141-218.
March 21, 2023................. 200-745 Parnell Technologies RESPIRMYCIN 25 Original approval for FOI Summary.............. 522.2630
Pty. Ltd., Unit 4, (tulathromycin the treatment of
476 Gardeners Rd., injection) Injectable respiratory disease
Alexandria, New South Solution. in swine and calves
Wales 2015, Australia. as a generic copy of
NADA 141-349.
March 29, 2023................. 200-744 Provetica LLC, 8735 MODULIS for Cats Original approval for FOI Summary.............. 520.522
Rosehill Rd., Suite (cyclosporine oral the control of feline
300, Lenexa, KS 66215. solution) USP allergic dermatitis
MODIFIED. in cats as a generic
copy of NADA 141-329.
March 30, 2023................. 200-746 Norbrook Laboratories TAURAMOX (moxidectin) Original approval for FOI Summary.............. 522.1450
Ltd., Carnbane Injectable Solution. treatment and control
Industrial Estate, of internal and
Newry, County Down, external parasites in
BT35 6QQ, United beef and nonlactating
Kingdom. dairy cattle as a
generic copy of NADA
141-220.
March 31, 2023................. 200-747 ZyVet Animal Health, Maropitant Citrate Original approval for FOI Summary.............. 520.1315
Inc., 73 Route 31N, (maropitant citrate) the prevention of
Pennington, NJ 08534. Tablets. acute vomiting and
the prevention of
vomiting due to
motion sickness in
dogs as a generic
copy of NADA 141-262.
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Also, FDA is amending the animal drug regulations to reflect
approval of supplemental applications, as listed in table 2, to change
the marketing status of dosage form antimicrobial animal drug products
from over the counter (OTC) to by veterinary prescription (Rx). These
applications were submitted in voluntary compliance with the goals of
the FDA Center for Veterinary Medicine's (CVM's) Judicious Use
Initiative as identified by guidance for industry #263,
``Recommendations for Sponsors of Medically Important Antimicrobial
Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary
Oversight All Products That Continue to be Available Over-the-
Counter,'' June 11, 2021 (<a href="https://www.fda.gov/media/130610/download">https://www.fda.gov/media/130610/download</a>).
Table 2--Supplemental Applications Approved During January, February, and March 2023 To Change the Marketing
Status of Antimicrobial Animal Drug Products From OTC to Rx
----------------------------------------------------------------------------------------------------------------
21 CFR
Approval date File No. Sponsor Product name section
----------------------------------------------------------------------------------------------------------------
January 3, 2022....................... 200-274 Zoetis Inc., 333 LINCOMIX (lincomycin 522.1260
Portage St., hydrochloride)
Kalamazoo, MI 49007. Injectable Solution.
January 12, 2022...................... 012-123 Bimeda Animal Health GALLIMYCIN 100 522.820
Ltd., 1B The Herbert Injection
Building, The Park, (erythromycin)
Carrickmines, Dublin Injectable Solution.
18, Ireland.
January 12, 2022...................... 130-952 Intervet, Inc., 2 GENTOCIN Pinkeye Spray 524.1044e
Giralda Farms, (gentamicin) Topical
Madison, NJ 07940. Spray.
January 13, 2022...................... 008-774 Huvepharma EEOD, 5th SULMET (sodium 522.2260
Floor, 3A Nikolay sulfamethazine)
Haytov Str., 1113 Injectable Solution.
Sofia, Bulgaria.
February 10, 2023..................... 065-506 Bimeda Animal Health COMBI-PEN-48 522.1696a
Ltd., 1B The Herbert (penicillin G
Building, The Park, benzathine and
Carrickmines, Dublin penicillin G
18, Ireland. procaine) Injectable
Suspension.
February 14, 2023..................... 055-018 Huvepharma EOOD, 5th Chlortetracycline 520.443
Floor, 3A Nikolay (chlortetracycline
Haytov Str., 1113 hydrochloride)
Sofia, Bulgaria. Tablets, 25 mg.
February 15, 2023..................... 033-157 Do.................... SPECTAM Scour-Halt 520.2123c
(spectinomycin) Oral
Solution.
February 15, 2023..................... 040-040 Do.................... SPECTAM 522.2120
(spectinomycin)
Injectable Solution.
February 24, 2023..................... 065-010 Do.................... NOROCILLIN (penicillin 522.1696b
G procaine)
Injectable Suspension.
March 1, 2023......................... 200-351 Do.................... Lincomycin Injectable, 522.1260
USP.
March 1, 2023......................... 200-368 Do.................... Lincomycin Injectable, 522.1260
USP.
March 1, 2023......................... 130-464 Intervet, Inc., 2 GARACIN Pig Pump 520.1044b
Giralda Farms, (gentamicin) Oral
Madison, NJ 07940. Solution.
[[Page 27696]]
March 9, 2023......................... 035-456 Bimeda Animal Health GALLIMYCIN-36 526.820
Ltd., 1B The Herbert (erythromycin)
Building, The Park, Intramammary Solution.
Carrickmines, Dublin
18, Ireland.
March 13, 2023........................ 200-315 Sparhawk Laboratories, LINCOMYCIN 300 522.1260
Inc., 12340 Santa Fe (lincomycin
Trail Dr., Lenexa, KS hydrochloride)
66215. Injectable Solution.
March 16, 2023........................ 065-505 Bimeda Animal Health PRO-PEN-G (penicillin 522.1696b
Ltd., 1B The Herbert G procaine)
Building, The Park, Injectable Suspension.
Carrickmines, Dublin
18, Ireland.
March 20, 2023........................ 200-127 Zoetis Inc., 333 PROSPEC (spectinomycin 522.2120
Portage St., hydrochloride)
Kalamazoo, MI 49007. Injectable Solution.
March 25, 2023........................ 040-181 Huvepharma EOOD, 5th VETSULID 520.2200
Floor, 3A Nikolay (sulfachlorpyridazine
Haytov Str., 1113 ) Oral Suspension.
Sofia, Bulgaria.
March 28, 2023........................ 065-081 HQ Specialty Pharma MASTI-CLEAR 526.1696
Corp., 120 Rte. 17 (penicillin G
North, Suite 130, procaine) Suspension
Paramus, NJ 07652. and GO-DRY
(penicillin G
procaine) Suspension.
----------------------------------------------------------------------------------------------------------------
II. Withdrawals of Approval
Elanco US Inc. (Elanco), 2500 Innovation Way, Greenfield, IN 46140
has requested that FDA withdraw approval of conditionally approved NADA
141-527 for BAYTRIL 100-CA1 (enrofloxacin) Injectable Solution.
Pursuant to Elanco's request, approval of their application was
withdrawn on March 31, 2023. As provided in the regulatory text of this
document, the animal drug regulations in 21 CFR 516.812 are removed to
reflect this action.
Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd.,
Duluth, GA 30096 has requested that FDA withdraw approval of the 49
applications listed in table 3 because the products are no longer
manufactured or marketed. As provided in the regulatory text of this
document, the animal drug regulations are amended where appropriate to
reflect this action.
Table 3--Applications for Which Approval Was Voluntarily Withdrawn by FDA
----------------------------------------------------------------------------------------------------------------
File No. Product name 21 CFR cite
----------------------------------------------------------------------------------------------------------------
006-623......................................... CAPARSOLATE (arsenamide sodium) Injectable Not
Solution. codified
008-422......................................... SELEEN (selenium disulfide) Topical Suspension... 524.2101
010-424......................................... NALLINE (nalorphine hydrochloride) Injectable 522.1452
Solution.
011-080......................................... HYDELTRONE-TBA (prednisolone tertiary 522.1885
butylacetate) Injectable Suspension.
011-437......................................... HYDELTRONE (neomycin sulfate and prednisolone 524.1484j
sodium phosphate) Ointment.
011-532......................................... SULFABROM (sulfabromomethazine sodium) Bolus..... 520.2170
011-678......................................... DIURIL (chlorothiazide) Tablets.................. 520.420
012-734......................................... DIURIL (chlorothiazide) Bolus.................... 520.420
013-022......................................... THIBENZOLE (thiabendazole) Sheep & Goat Wormer... 520.2380c
013-407......................................... EQUIZOLE (thiabendazole) Horse Wormer Top Dress.. 520.2380a
013-624......................................... Triamcinolone Acetonide Tablets.................. 520.2483
013-674......................................... HYDROZIDE (hydrochlorothiazide) Injectable 522.1150
Solution.
013-954......................................... THIBENZOLE (thiabendazole) 20% Swine Premix...... 558.600
014-350......................................... OMNIZOLE (thiabendazole) Oral Liquid............. 520.2380b
015-123......................................... TBZ (thiabendazole) Cattle Wormer Oral Liquid.... 520.2380b
015-875......................................... TBZ 200 (thiabendazole) Medicated Feed Premix.... 558.600
030-103......................................... THIBENZOLE (thiabendazole) Oral Liquid........... 520.2380b
032-702......................................... PROM ACE (acepromazine maleate) Tablets.......... 520.23
033-127......................................... VETISULID (sulfachlorpyridazine) Bolus........... 520.2200
033-318......................................... VETISULID (sulfachlorpyridazine) Injectable 520.2200
Solution.
033-319......................................... VETISULID (sulfachlorpyridazine) Tablets......... 520.2200
034-114......................................... EQUIZOLE (thiabendazole) Oral Liquid............. 520.2380b
034-879......................................... DOPRAM-V (doxapram hydrochloride) Injectable 522.775
Solution.
035-631......................................... THIBENZOLE (thiabendazole) Pig Wormer............ 520.2380b
037-410......................................... EQUIZOLE A (thiabendazole and piperazine 520.2380e
phosphate) Oral Liquid.
043-141......................................... THIBENZOLE 300 (thiabendazole) Medicated......... 558.600
044-654......................................... EQUIZOLE (thiabendazole) Horse Wormer Pellets.... 520.2380a
046-146......................................... VETALOG (triamcinolone acetonide) Cream.......... 524.2483
047-333......................................... EQUIZOLE A (thiabendazole and piperazine citrate) 520.2380d
Oral Liquid.
048-487......................................... TBZ (thiabendazole) Wormer Paste 50%............. 520.2380b
049-461......................................... TBZ (thiabendazole) Wormer Paste 43%............. 520.2380b
055-021......................................... HETACIN K (hetacillin potassium) Capsules Vet.... 520.1130
055-022......................................... HETACIN K (hetacillin potassium) Tablets......... 520.1130
055-048......................................... HETACIN K (hetacillin potassium) Oral Liquid..... 520.1130
065-275......................................... Penicillin VK (penicillin V potassium) Filmtab 520.1696c
Tablets 250 mg.
065-276......................................... VEESYN (penicillin V potassium) Granules for Oral 520.1696b
Solution.
093-600......................................... VOREN (dexamethasone-21-isonicotinate) Suspension 522.542
[[Page 27697]]
094-642......................................... CAMVET (cambendazole) Suspension Horse Wormer.... 520.284a
095-642......................................... OXY-TET (oxytetracycline hydrochloride) 522.1662a
Injectable Solution.
096-506......................................... CAMVET (cambendazole) Horse Wormer Pellets....... 520.284b
096-731......................................... CAMVET (cambendazole) Horse Wormer Paste 45%..... 520.284c
098-689......................................... EQUIZOLE (thiabendazole) 50% Wormer Paste........ 520.2380b
099-388......................................... VETALOG (triamcinolone acetonide) Oral Powder.... 520.2483
117-531......................................... Acepromazine Maleate Injection................... 522.23
127-443......................................... EQVALAN (ivermectin) Injectable Solution......... 522.1192
140-439......................................... EQVALAN (ivermectin) Oral Liquid For Horses...... 522.1195
141-180......................................... TORPEX (albuterol sulfate)....................... 529.40
200-361......................................... Acepromazine Maleate Injection................... 522.23
200-564......................................... Ivermectin Paste 1.87%........................... 520.1192
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III. Technical Amendments
FDA is making the following amendments to improve the accuracy of
the animal drug regulations.
<bullet> 21 CFR 520.48 is amended to reflect the sponsors of
products containing altrenogest for use in horses and swine.
<bullet> 21 CFR 520.2380 is removed and 21 CFR 558.600 revised to
characterize a free-choice block containing thiabendazole as a new
animal drug for use in cattle feed.
<bullet> 21 CFR 522.1077 is amended to reflect indications for use
of gonadorelin in cattle.
<bullet> 21 CFR 522.1222 is amended to reflect sponsors of approved
applications for use of ketamine in cats and subhuman primates.
<bullet> 21 CFR 556.620 is removed because there are no longer any
approved products containing sulfabromomethazine for use in food-
producing animals.
<bullet> 21 CFR 556.730 is revised to reflect the removal of
products containing thiabendazole for use in food-producing animals
other than cattle.
<bullet> 21 CFR 558.311 is amended to reflect approved classes of
pasture cattle for use of lasalocid medicated feeds.
<bullet> 21 CFR 558.455 is amended to reflect the approved
conditions of use of medicated feeds containing oxytetracycline and
neomycin in sheep.
IV. Legal Authority
This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)), which requires
Federal Register publication of ``notice[s] . . . effective as a
regulation,'' of the conditions of use of approved new animal drugs.
This rule sets forth technical amendments to the regulations to codify
recent actions on approved new animal drug applications and corrections
to improve the accuracy of the regulations, and as such does not impose
any burden on regulated entities.
Although denominated a rule pursuant to the FD&C Act, this document
does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because
it is a ``rule of particular applicability.'' Therefore, it is not
subject to the congressional review requirements in 5 U.S.C. 801-808.
Likewise, this is not a rule subject to Executive Order 12866, which
defines a rule as ``an agency statement of general applicability and
future effect, which the agency intends to have the force and effect of
law, that is designed to implement, interpret, or prescribe law or
policy or to describe the procedure or practice requirements of an
agency.''
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 516
Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, 526, and 529
Animal drugs.
21 CFR Part 556
Animal drugs, Dairy products, Foods, Meat and meat products.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
510, 516, 520, 522, 524, 526, 529, 556, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for part 510 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600:
0
a. In paragraph (c)(1), amend the table by adding an entry for
``Provetica LLC''; and
0
b. In paragraph (c)(2), amend the table by adding add an entry for
``086097''.
The additions read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
[[Page 27698]]
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * * * *
Provetica LLC, 8735 Rosehill Rd., Suite 300, 086097
Lenexa, KS 66215.................................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
086097...................... Provetica LLC, 8735 Rosehill Rd., Suite
300, Lenexa, KS 66215.
* * * * * * *
------------------------------------------------------------------------
PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
0
3. The authority citation for part 516 continues to read as follows:
Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.
Sec. 516.812 [Removed]
0
4. Remove Sec. 516.812.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
5. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
6. In Sec. 520.48, revise paragraph (b) to read as follows:
Sec. 520.48 Altrenogest.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter:
(1) Nos. 000061 and 051072 for use as in paragraph (d) of this
section.
(2) No. 061133 for use as in paragraph (d)(1) of this section.
(3) No. 013744 for use as in paragraph (d)(2) of this section.
* * * * *
Sec. Sec. 520.284, 520.284a, 520.284b, and 520.284c [Removed]
0
7. Remove Sec. Sec. 520.284, 520.284a, 520.284b, and 520.284c.
0
8. In Sec. 520.304, revise paragraphs (b)(1) and (2) to read as
follows:
Sec. 520.304 Carprofen.
* * * * *
(b) * * *
(1) Nos. 017033, 054771, 055529, 062250, and 086101 for use of
products described in paragraph (a)(1) and (2) of this section as in
paragraph (c) of this section.
(2) Nos. 058198 and 086117 for use of product described in
paragraph (a)(2) as in paragraph (c) of this section.
* * * * *
Sec. Sec. 520.420 [Removed]
0
9. Remove Sec. 520.420.
0
10. In Sec. 520.443, amend paragraph (d)(2)(ii) by adding a sentence
at the end of the paragraph to read as follows:
Sec. 520.443 Chlortetracycline tablets and boluses.
* * * * *
(d) * * *
(2) * * *
(ii) * * * Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
* * * * *
0
11. In Sec. 520.522, add paragraph (b)(4) and revise (d)(2)(ii) to
read as follows:
Sec. 520.522 Cyclosporine.
* * * * *
(b) * * *
(4) No. 086097 for use of product described in paragraph (a)(2) as
in paragraph (d) of this section.
* * * * *
(d) * * *
(2) * * *
(ii) Indications for use. For the control of feline allergic
dermatitis as manifested by excoriations (including facial and neck),
miliary dermatitis, eosinophilic plaques, and self-induced alopecia in
cats at least 6 months of age and at least 3 lbs (1.4 kg) in body
weight.
* * * * *
Sec. 520.812 [Amended]
0
12. Amend Sec. 520.812 by:
0
a. In paragraph (b)(2), removing ``No. 017033'' and in its place adding
``Nos. 017033 and 086117''; and
0
b. Removing paragraph (b)(4).
0
13. In Sec. 520.998, revise paragraph (c)(2)(i) to read as follows:
Sec. 520.998 Fluralaner.
* * * * *
(c) * * *
(2) * * *
(i) Chewable tablets described in paragraph (a)(1) of this section.
Kills adult fleas; for the treatment and prevention of flea
infestations (Ctenocephalides felis), and the treatment and control of
tick infestations (Ixodes scapularis (black-legged tick), Dermacentor
variabilis (American dog tick), Rhipicephalus sanguineus (brown dog
tick), and Haemaphysalis longicornis (Asian longhorned tick)) for 12
weeks in dogs and puppies 6 months of age and older, and weighing 4.4
lbs or greater; and for the treatment and control of Amblyomma
americanum (lone star tick) infestations for 8 weeks in dogs and
puppies 6 months of age and older, and weighing 4.4 lbs or greater.
* * * * *
0
14. Amend Sec. 520.1044b by adding a sentence at the end of paragraph
(d)(3) to read as follows:
Sec. 520.1044b [Amended]
* * * * *
(d) * * *
(3) * * * Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
Sec. 520.1130 [Removed]
0
15. Remove Sec. Sec. 520.1130.
Sec. 520.1195 [Amended]
0
16. In Sec. 520.1195, in paragraph (b)(1), remove ``000010,''.
0
17. In Sec. 520.1310, revise paragraphs (a) and (b) to read as
follows:
[[Page 27699]]
Sec. 520.1310 Marbofloxacin.
(a) Specifications. Each tablet or chewable tablet contains 25, 50,
100, or 200 milligrams (mg) marbofloxacin.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (d) of this section:
(1) Nos. 017033, 054771, and 086117 for use of tablets.
(2) No. 086101 for use of chewable tablets.
* * * * *
0
18. In Sec. 520.1315, revise paragraph (b) to read as follows:
Sec. 520.1315 Maropitant.
* * * * *
(b) Sponsors. See Nos. 054771 and 086117 in Sec. 510.600(c) of
this chapter.
* * * * *
Sec. 520.1696b [Removed]
0
19. Remove Sec. 520.1696b.
0
20. In Sec. 520.1696c, revise paragraph (b) to read as follows:
Sec. 520.1696c Penicillin V tablets.
* * * * *
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
* * * * *
Sec. 520.1870 [Amended]
0
21. In Sec. 520.1870, in paragraph (b)(2), remove ``No. 069043'' and
in its place add ``Nos. 069043 and 086101''.
0
22. In Sec. 520.2200, revise paragraph (a)(2), remove paragraph
(a)(3), revise paragraphs (d)(1)(i) and (d)(2)(i), and remove (d)(3) to
read as follows:
Sec. 520.2200 Sulfachlorpyridazine.
(a) * * *
(2) Each milliliter (mL) of suspension contains 50 milligrams (mg)
of sodium sulfachlorpyridazine.
* * * * *
(d) * * *
(1) * * *
(i) Amount. Administer 30 to 45 mg sulfachlorpyridazine powder per
pound (/lb) of body weight per day in milk or milk replacer in divided
doses twice daily for 1 to 5 days.
* * * * *
(2) * * *
(i) Amount. Administer 20 to 35 mg/lb body weight per day in
divided doses twice daily for 1 to 5 days in drinking water or an oral
suspension containing 50 mg per mL.
* * * * *
Sec. Sec. 520.1696b, 520.2170, 520.2380, 520.2380a, 520.2380b,
520.2380c, 520.2380d and 520.2380e [Removed]
0
23. Remove Sec. Sec. 520.1696b, 520.2170, 520.2380, 520.2380a,
520.2380b, 520.2380c, 520.2380d and 520.2380e.
Sec. 520.2380f [Redesignated]
0
24. Redesignate Sec. 520.2380f as Sec. 520.2382.
Sec. 520.2483 [Removed]
0
25. Remove Sec. 520.2483.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
26. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 522.536 [Amended]
0
27. In Sec. 522.536, in paragraph (b), remove ``Nos. 015914 and
052483'' and in its place add ``Nos. 015914, 052483, and 059399''.
Sec. 522.542 [Removed]
0
28. Remove Sec. 522.542.
Sec. 522.558 [Amended]
0
29. In Sec. 522.558, in paragraph (b)(1), remove ``Nos. 017033 and
059399'' and in its place add ``Nos. 017033, 059399, and 086117''.
Sec. 522.775 [Removed]
0
30. Remove Sec. 522.775.
0
31. Amend Sec. 522.820 by adding a sentence at the end of paragraph
(d)(3)(iii) to read as follows:
Sec. 522.820 Erythromycin.
* * * * *
(d) * * *
(3) * * *
(iii) * * * Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
0
32. In Sec. 522.1077, revise paragraphs (b)(2), (d)(1)(iv), and
(e)(1)(i) to read as follows:
Sec. 522.1077 Gonadorelin.
* * * * *
(b) * * *
(2) No. 068504 for use of the 100-[micro]g/mL product described in
paragraph (a)(2) as in paragraphs (d)(1)(i) and (iv) of this section.
* * * * *
(d) * * *
(1) * * *
(iv) Dinoprost injection for use as in paragraph (e)(1)(vi) of this
section as provided by No. 054771 in Sec. 510.600(c) of this chapter.
* * * * *
(e) * * *
(1) * * *
(i) For the treatment of ovarian follicular cysts in dairy cattle:
Administer 86 [micro]g gonadorelin (No. 000061), or 100 [micro]g
gonadorelin diacetate tetrahydrate (Nos. 000010 and 061133), or 100
[micro]g gonadorelin (as gonadorelin acetate; No. 068504) by
intramuscular or intravenous injection.
* * * * *
Sec. 522.1150 [Removed]
0
33. Remove Sec. 522.1150.
0
34. In Sec. 522.1192, remove and reserve paragraph (a)(1), and revise
paragraphs (b)(1) and (2), remove and reserve paragraph (e)(1), and
revise paragraph (e)(2)(i) to read as follows:
Sec. 522.1192 Ivermectin.
* * * * *
(b) * * *
(1) Nos. 000010, 016592, 055529, 058005, and 061133 for use of the
product described in paragraph (a)(2) of this section as in paragraphs
(e)(2) through (e)(5) of this section; and
(2) No. 000010 for use of the product described in paragraph (a)(3)
of this section as in paragraphs (e)(3) and (e)(6) of this section.
* * * * *
(e) * * *
(2) * * *
(i) Amount. 200 micrograms per kilogram ([micro]g/kg) of body
weight by subcutaneous injection.
* * * * *
Sec. 522.1222 [Amended]
0
35. In Sec. 522.1222, revise paragraph (b) by adding, in numeric
sequence, ``00010,''.
0
36. In Sec. 522.1450, revise paragraphs (a), (b), and (e) to read as
follows:
Sec. 522.1450 Moxidectin solution.
(a) Specifications. Each milliliter (mL) of solution contains 10
milligrams (mg) moxidectin.
(b) Sponsors. See Nos. 055529 and 058198 in Sec. 510.600(c) of
this chapter.
* * * * *
(e) Conditions of use in cattle--(1) Amount. Administer by
subcutaneous injection 1 mL for each 110 pounds (lb) (50 kilograms
(kg)) body weight to provide 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body
weight.
(2) Indications for use. Beef and nonlactating dairy cattle: For
treatment and control of Gastrointestinal roundworms: Ostertagia
ostertagi (adults, fourth-stage larvae, and inhibited larvae),
Haemonchus placei (adults), Trichostrongylus axei (adults and fourth-
stage larvae), Trichostrongylus colubriformis (adults and fourth-stage
larvae), Cooperia oncophora (adults), Cooperia pectinata (adults),
Cooperia punctata (adults and fourth-stage larvae), Cooperia spatulata
(adults), Cooperia surnabada (adults
[[Page 27700]]
and fourth-stage larvae), Nematodirus helvetianus (adults),
Oesophagostomum radiatum (adults and fourth-stage larvae), Trichuris
spp. (adults); Lungworms: Dictyocaulus viviparus (adults and fourth-
stage larvae); Cattle grubs: Hypoderma bovis and Hypoderma lineatum;
Mites: Psoroptes ovis (Psoroptes communis var. bovis); Lice:
Linognathus vituli and Solenopotes capillatus. For protection from
reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum
for 42 days after treatment, with Haemonchus placei for 35 days after
treatment, and with Ostertagia ostertagi and Trichostrongylus axei for
14 days after treatment.
(3) Limitations. Cattle must not be slaughtered for human
consumption within 21 days of treatment. This drug product is not
approved for use in female dairy cattle 20 months of age or older,
including dry dairy cows. Use in these cattle may cause drug residues
in milk and/or in calves born to these cows. A withdrawal period has
not been established for preruminating calves. Do not use in calves to
be processed for veal.
Sec. 522.1696b [Amended]
0
37. In Sec. 522.1696b, amend paragraph (d)(2)(iii)(C), by removing
``For Nos. 054771 and 055529:''.
Sec. 522.1885 [Removed]
0
38. Remove Sec. 522.1885.
0
39. Amend Sec. 522.2120 by adding a sentence at the end of paragraph
(d)(1)(ii) to read follows:
Sec. 522.2120 Spectinomycin hydrochloride.
* * * * *
(d) * * *
(1) * * *
(ii) * * * Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
* * * * *
Sec. 522.2200 [Removed]
0
40. Remove Sec. 522.2200.
0
41. In 522.2630, revise paragraph (b)(2) to read as follows:
Sec. 522.2630 Tulathromycin.
* * * * *
(b) * * *
(2) Nos. 013744, 051311, 054771, 058198, and 068504 for use of
product described in paragraph (a)(2) as in paragraphs (d)(1)(i),
(d)(1)(ii)(B), (d)(1)(iii)(B), and (d)(2) of this section.
* * * * *
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
42. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
43. In Sec. 524.770, revise paragraph (b) to read as follows:
Sec. 524.770 Doramectin.
* * * * *
(b) Sponsors. See Nos. 051072 and 054771 in Sec. 510.600(c) of
this chapter.
* * * * *
0
44. In Sec. 524.814, revise paragraphs (b) and (e)(1) to read as
follows:
Sec. 524.814 Eprinomectin.
* * * * *
(b) Sponsors. See Nos. 000010, 051072, and 055529 in Sec.
510.600(c) of this chapter.
* * * * *
(e) * * *
(1) Amount. Apply 5 mg (1 mL) per 10 kilograms (kg) of body weight
(500 micrograms/kg) topically along backbone from withers to tailhead.
* * * * *
Sec. 524.1044e [Amended]
0
45. Amend Sec. 524.1044e by adding a sentence at the end of paragraph
(d)(3) to read as follows:
Sec. 524.1044e Gentamicin spray.
* * * * *
(d) * * *
(3) * * * Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
Sec. 524.1146 [Amended]
0
46. In Sec. 524.1146, in paragraph (b)(3), remove ``Nos. 051072 and
058198'' and in its place add ``Nos. 051072, 055529, 058198, and
061651''.
Sec. 524.1484j [Removed]
0
47. Remove Sec. 524.1484j.
Sec. 524.2101 [Amended]
0
48. In Sec. 524.2101, in paragraph (b), remove ``000010, 000061,'' and
in its place add ``000061''.
Sec. 524.2483 [Amended]
0
49. In Sec. 524.2483, in paragraph (b), remove ``Nos. 000010 and
054925'' and in its place add ``No. 054925''.
PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
0
50. The authority citation for part 526 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
51. Amend Sec. 526.1696 by adding a sentence at the end of paragraph
(d)(3) and paragraph (e)(3) to read as follows:
Sec. 526.1696 Penicillin G procaine.
* * * * *
(d) * * *
(3) * * * For No. 042791: Federal law restricts this drug to use by
or on the order of a licensed veterinarian.
(e)
(3) * * * For No. 042791: Federal law restricts this drug to use by
or on the order of a licensed veterinarian.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
52. The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 529.40 [Removed]
0
53. Remove Sec. 529.40.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
54. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
Sec. 556.620 [Removed]
0
55. Remove Sec. 556.620.
0
56. Revise Sec. 556.730 to read as follows:
Sec. 556.730 Thiabendazole.
(a) [Reserved]
(b) Tolerances. The tolerances for thiabendazole are:
(1) Cattle--(i) Edible tissues (excluding milk): 0.1 ppm.
(ii) Milk: 0.05 ppm.
(2) [Reserved]
(c) Related conditions of use. See Sec. 558.600.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
57. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
58. In Sec. 558.311, revise paragraph (e)(3)(iii) to read as follows:
Sec. 558.311 Lasalocid.
* * * * *
(e) * * *
(3) * * *
[[Page 27701]]
----------------------------------------------------------------------------------------------------------------
Lasalocid amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(iii) Not less than 60 mg or more than Pasture cattle (slaughter, Feed continuously at a rate 054771
300 mg of lasalocid per head per day. stocker, feeder cattle, of not less than 60 mg or
and beef replacement more than 300 mg of
heifers): For increased lasalocid per head per day
rate of weight gain. when on pasture. The drug
must be contained in at
least 1 pound of feed.
Daily intakes of lasalocid
in excess of 200 mg/head/
day have not been shown to
be more effective than 200
mg/head/day.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
50. In Sec. 558.455, revise paragraph (e)(5) to read as follows:
Sec. 558.455 Oxytetracycline and neomycin.
* * * * *
(e) * * *
(5) Sheep. It is used in feed as follows:
----------------------------------------------------------------------------------------------------------------
Oxytetracycline and neomycin sulfate
amount Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) To provide 10 mg/lb of body weight Sheep: For treatment of Feed continuously for 7 to 066104
daily. bacterial enteritis caused 14 days. Treatment should 069254
by Escherichia coli and continue 24 to 48 hours
bacterial pneumonia caused beyond remission of
by Pasteurella multocida clinical signs of disease.
susceptible to Withdraw 5 days before
oxytetracycline; treatment slaughter.
and control of
colibacillosis (bacterial
enteritis) caused by E.
coli susceptible to
neomycin.
----------------------------------------------------------------------------------------------------------------
(ii) [Reserved]
0
59. Revise Sec. 558.600 to read as follows:
Sec. 558.600 Thiabendazole.
(a) Specifications. Mineral protein block containing 3.3 percent
thiabendazole.
(b) Sponsor. See No. 012286 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.730 of this chapter.
(d) Special considerations. See Sec. 500.25 of this chapter.
(e) Conditions of use in cattle--(1) Amount. Provide free-choice to
cattle on pasture or range accustomed to mineral protein block feeding
for 3 days. Cattle should consume at a recommended level of 0.11 pound
per 100 pounds of body weight per day. Animals maintained under
conditions of constant worm exposure may require re-treatment within 2
to 3 weeks.
(2) Indications for use. For control of infections of
gastrointestinal roundworms (Trichostrongylus, Haemonchus, Ostertagia,
and Cooperia).
(3) Limitations. Milk taken from animals during treatment and
within 96 hours (8 milkings) after the latest treatment must not be
used for food. Do not treat cattle within 3 days of slaughter.
Dated: April 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09212 Filed 5-2-23; 8:45 am]
BILLING CODE 4164-01-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.