Notice2021-23084
Determination That ROBAXIN and ROBAXIN-750 (Methocarbamol), Oral Tablets, 500 Milligrams and 750 Milligrams, and Other Drug Products, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
October 22, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Full Text
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<title>Federal Register, Volume 86 Issue 202 (Friday, October 22, 2021)</title>
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[Federal Register Volume 86, Number 202 (Friday, October 22, 2021)]
[Notices]
[Pages 58674-58675]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-23084]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1038]
Determination That ROBAXIN and ROBAXIN-750 (Methocarbamol), Oral
Tablets, 500 Milligrams and 750 Milligrams, and Other Drug Products,
Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
these drug products, and it will allow FDA to continue to approve ANDAs
that refer to the products as long as they meet relevant legal and
regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363,
<a href="/cdn-cgi/l/email-protection#8ddef9eceef4a3c6ece3e8cdebe9eca3e5e5fea3eae2fb"><span class="__cf_email__" data-cfemail="b5e6c1d4d6cc9bfed4dbd0f5d3d1d49bddddc69bd2dac3">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) Has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all approved drugs. FDA publishes this list as part of the ``Approved
Drug Products With Therapeutic Equivalence Evaluations,'' which is
generally known as the ``Orange Book.'' Under FDA regulations, a drug
is removed from the list if the Agency withdraws or suspends approval
of the drug's NDA or ANDA for reasons of safety or effectiveness, or if
FDA determines that the listed drug was withdrawn from sale for reasons
of safety or effectiveness (21 CFR 314.162).
Under Sec. 314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for safety or
effectiveness reasons, the Agency will initiate proceedings that could
result in the withdrawal of approval of the ANDAs that refer to the
listed drug.
FDA has become aware that the drug products listed in the table are
no longer being marketed.
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Active Dosage form/
Application No. Drug name ingredient(s) Strength(s) route Applicant
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NDA 011011.......... ROBAXIN; ROBAXIN- Methocarbamol.... 500 milligrams Tablet; Oral.... Auxilium
750. (mg); 750 mg. Pharmaceuticals
LLC.
NDA 018704.......... LOPRESSOR........ Metoprolol 1 mg/milliliter Injectable; Novartis.
Tartrate. (mL). Injection.
NDA 018917.......... SECTRAL.......... Acebutolol Equivalent to Capsule; Oral... Promius Pharma,
Hydrochloride. (EQ) 200 mg LLC.
base; EQ 400 mg
base.
NDA 019546.......... DYNACIRC......... Isradipine....... 2.5 mg; 5 mg.... Capsule; Oral... SmithKline
Beecham.
NDA 019555.......... DIPROLENE AF..... Betamethasone EQ 0.05% base... Cream, Merck Sharp
Dipropionate. Augmented; Dohme.
Topical.
NDA 019625.......... ELOCON........... Mometasone 0.10%........... Cream; Topical.. Merck Sharp
Furoate. Dohme.
NDA 020089.......... ZOVIRAX.......... Acyclovir........ 400 mg; 800 mg.. Tablet; Oral.... Mylan.
NDA 020136.......... DEMADEX.......... Torsemide........ 5 mg; 10 mg; 20 Tablet; Oral.... Mylan Specialty,
mg; 100 mg. L.P.
NDA 020198.......... ADALAT CC........ Nifedipine....... 30 mg; 60 mg; 90 Tablet, Extended Alvogen.
mg. Release; Oral.
NDA 020539.......... LAMISIL.......... Terbinafine EQ 250 mg base.. Tablet; Oral.... Novartis.
Hydrochloride.
NDA 020634.......... LEVAQUIN......... Levofloxacin..... 250 mg; 500 mg; Tablet; Oral.... Janssen Research
750 mg. & Development,
LLC.
NDA 020716.......... VICOPROFEN....... Hydrocodone 7.5 mg; 200 mg.. Tablet; Oral.... Abbvie, Inc.
Bitartrate;
Ibuprofen.
NDA 020738.......... TEVETEN.......... Eprosartan EQ 300 mg base; Tablet; Oral.... Abbvie, Inc.
Mesylate. EQ 400 mg base;
EQ 600 mg base.
NDA 021001.......... AXERT............ Almotriptan EQ 6.25 mg base; Tablet; Oral.... Janssen Pharms.
Malate. EQ 12.5 mg base.
NDA 022205.......... GIAZO............ Balsalazide 1.1 gram........ Tablets; Oral... Valeant Pharms.
Disodium. International.
NDA 022439.......... ZUTRIPRO......... Chlorpheniramine 4 mg/5 mL; 5 mg/ Solution; Oral.. Persion Pharms,
Maleate, 5 mL; 60 mg/5 LLC.
Hydrocodone mL.
Bitartrate, and
Pseudoephedrine
Hydrochloride.
[[Page 58675]]
NDA 022510.......... ABSTRAL.......... Fentanyl Citrate. EQ 0.1 mg base; Tablet; Sentynl
EQ 0.2 mg base; Sublingual. Therapeutics,
EQ 0.3 mg base; Inc.
EQ 0.4 mg base;
EQ 0.6 mg base;
EQ 0.8 mg base.
NDA 050011.......... PATHOCIL......... Dicloxacillin EQ 250 mg base; Capsule; Oral... Wyeth-Ayerst
Sodium. EQ 500 mg base. Labs.
NDA 204308.......... EPANED KIT....... Enalapril Maleate 1 mg/mL......... For Solution; Silvergate
Oral. Pharms., Inc.
NDA 207233.......... VIVLODEX......... Meloxicam........ 5 mg; 10 mg..... Capsule; Oral... Zyla.
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FDA has reviewed its records and, under Sec. 314.161, has
determined that the drug products listed were not withdrawn from sale
for reasons of safety or effectiveness. Accordingly, the Agency will
continue to list the drug products in the ``Discontinued Drug Product
List'' section of the Orange Book. The Discontinued Drug Product List
identifies, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness.
Approved ANDAs that refer to the NDAs listed are unaffected by the
discontinued marketing of the products subject to those NDAs.
Additional ANDAs that refer to these products may also be approved by
the Agency if they comply with relevant legal and regulatory
requirements. If FDA determines that labeling for these drug products
should be revised to meet current standards, the Agency will advise
ANDA applicants to submit such labeling.
Dated: October 19, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23084 Filed 10-21-21; 8:45 am]
BILLING CODE 4164-01-P
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