Notice2022-17056
Determination That AVC (Sulfanilamide) Vaginal Cream, 15%, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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Published
August 9, 2022
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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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 87 Issue 152 (Tuesday, August 9, 2022)</title>
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[Federal Register Volume 87, Number 152 (Tuesday, August 9, 2022)]
[Notices]
[Pages 48484-48486]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-17056]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1694]
Determination That AVC (Sulfanilamide) Vaginal Cream, 15%, 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Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety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withdrawn from sale for reasons of safety or effectiveness.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#46153227253f680d27282306202227682e2e3568212930"><span class="__cf_email__" data-cfemail="df8cabbebca6f194beb1ba9fb9bbbef1b7b7acf1b8b0a9">[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.
[[Page 48485]]
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Active
Application No. Drug name ingredient(s) Strength(s) Dosage form/route Applicant
----------------------------------------------------------------------------------------------------------------
NDA 006530........ AVC.............. Sulfanilamide.... 15%.............. Cream; Vaginal... Mylan Specialty
LP.
NDA 007936........ SELSUN........... Selenium Sulfide. 2.5%............. Lotion/Shampoo; Chattem, Inc.
Topical.
NDA 008816........ XYLOCAINE........ Lidocaine 2%............... Jelly; Topical... Akorn.
Hydrochloride.
NDA 009218........ COUMADIN......... Warfarin Sodium.. 1 Milligram (mg). Tablet; Oral..... Bristol Myers
Squibb.
NDA 012806........ CORDRAN SP....... Flurandrenolide.. 0.025%........... Cream; Topical... Almirall.
NDA 016647........ QUINAGLUTE....... Quinidine 324 mg........... Tablet, Extended Bayer
Gluconate. Release; Oral. Healthcare.
NDA 017386........ ZAROXOLYN........ Metolazone....... 2.5 mg; 5 mg; 10 Tablet; Oral..... Lannett Co.,
mg. Inc.
NDA 017531........ TIGAN............ Trimethobenzamide 300 mg........... Capsule; Oral.... King Pharms LLC.
Hydrochloride.
NDA 018081........ DEPAKENE......... Valproic Acid.... 250 mg........... Capsule; Oral.... AbbVie Inc.
NDA 018281........ TEGRETOL......... Carbamazepine.... 100 mg........... Tablet, Chewable; Novartis.
Oral.
NDA 018303........ LOPRESSOR HCT.... Hydrochlorothiazi 25mg; 100mg...... Tablet; Oral..... Validus Pharms.
de; Metoprolol
Tartrate.
NDA 018878........ INDOCIN.......... Indomethacin EQ 1 mg Base/Vial Injectable; Recordati Rare
Sodium. Injection. Diseases.
NDA 019404........ OCUFEN........... Flurbiprofen 0.03%............ Solution/Drops; Allergan.
Sodium. Ophthalmic.
NDA 019661........ CYTOVENE......... Ganciclovir EQ 500 mg Base/ Injectable; Cheplapharm.
Sodium. Vial. Injection.
NDA 019697........ ORTHO TRI-CYCLEN. Ethinyl 0.035 mg, 0.035 Tablet; Oral..... Janssen Pharms.
Estradiol; mg, 0.035 mg;
Norgestimate. 0.18 mg, 0.215
mg, 0.25 mg.
NDA 019766........ ZOCOR............ Simvastatin...... 80 mg............ Tablet; Oral..... Organon.
NDA 019814........ BETAGAN.......... Levobunolol 0.25%............ Solution/Drops; Allergan.
Hydrochloride. Ophthalmic.
NDA 019856........ SINEMET CR....... Carbidopa; 25 mg, 100 mg; 50 Tablet, Extended Organon.
Levodopa. mg, 200 mg. Release; Oral.
NDA 019907........ OPTIPRANOLOL..... Metipranolol 0.3%............. Solution/Drops; Bausch and Lomb.
Hydrochloride. Ophthalmic.
NDA 019968........ ULTRAVATE........ Halobetasol 0.05%............ Ointment; Topical Sun Pharm Inds.
Propionate. Inc.
NDA 020010........ LOTRISONE........ Betamethasone EQ 0.05% Base; 1% Lotion; Topical.. Merck Sharp
Dipropionate; Dohme.
Clotrimazole.
NDA 020381........ NIASPAN.......... Niacin........... 500 mg; 750 mg; Tablet, Extended AbbVie Inc.
1g. Release; Oral.
NDA 020412........ ZERIT............ Stavudine........ 15 mg; 20 mg; 30 Capsule; Oral.... Bristol Myers
mg; 40 mg. Squibb.
NDA 020509........ GEMZAR........... Gemcitabine EQ 200 mg Base/ Injectable; Lilly.
Hydrochloride. Vial; 1 Gram (g) Injection.
Base/Vial.
NDA 020593........ DEPACON.......... Valproate Sodium. 100 mg Base/ Injectable; AbbVie Inc.
Milliliter (mL). Injection.
NDA 020615........ DURACLON......... Clonidine 5 mg/10 mL (0.5 Injectable; Mylan
Hydrochloride. mg/mL). Injection. Institutional.
NDA 020718........ INTEGRILIN....... Eptifibatide..... 2 mg/mL; 75 mg/ Injectable; Merck Sharp
100 mL. Injection. Dohme.
NDA 021005........ SOLARAZE......... Diclofenac Sodium 3%............... Gel; Topical..... Fougera Pharms.
NDA 021085........ AVELOX........... Moxifloxacin EQ 400 mg Base... Tablet; Oral..... Bayer
Hydrochloride. Healthcare.
NDA 021183........ VIDEX EC......... Didanosine....... 125 mg; 200 mg; Capsule, Delayed Bristol Myers
250 mg; 400 mg. Release Pellets; Squibb.
Oral.
NDA 021241........ ORTHO TRI-CYCLEN Ethinyl 0.025 mg, 0.025 Tablet; Oral-28.. Janssen Pharms.
LO. Estradiol; mg, 0.025 mg;
Norgestimate. 0.18 mg, 0.215
mg, 0.25 mg.
NDA 021300........ CLARINEX......... Desloratadine.... 0.5 mg/mL........ Solution; Oral... Merck Sharp
Dohme.
NDA 021312........ CLARINEX......... Desloratadine.... 2.5 mg; 5 mg..... Tablet, Orally Organon.
Disintegrating;
Oral.
NDA 021372........ ALOXI............ Palonosetron EQ 0.25 mg Base/5 Injectable; Helsinn
Hydrochloride. mL (EQ 0.05 mg Intravenous. Healthcare.
Base/mL); EQ
0.075 mg Base/
1.5 mL (EQ 0.05
mg Base/mL).
NDA 021444........ RISPERDAL........ Risperidone...... 0.5 mg; 1 mg; 2 Tablet, Orally Janssen Pharms.
mg; 3 mg; 4 mg. Disintegrating;
Oral.
NDA 021455........ BONIVA........... Ibandronate EQ 150 mg Base... Tablet; Oral..... Hoffmann La
Sodium. Roche.
NDA 021605........ CLARINEX D 24 Desloratadine; 5 mg; 240 mg..... Tablet, Extended Organon.
HOUR. Pseudoephedrine Release; Oral.
Sulfate.
NDA 021858........ BONIVA........... Ibandronate EQ 3 mg Base/3 mL Injectable; Hoffmann La
Sodium. Intravenous. Roche.
NDA 021860........ SARAFEM.......... Fluoxetine EQ 10 mg Base; EQ Tablet; Oral..... Allergan.
Hydrochloride. 20 mg Base.
NDA 021956........ DUTOPROL......... Hydrochlorothiazi 12.5 mg; EQ 25 mg Tablet, Extended Concordia.
de; Metoprolol Tartrate; 12.5 Release; Oral.
Succinate. mg: EQ 50 mg
Tartrate; 12.5
mg; EQ 100 mg
Tartrate.
NDA 022064........ XYZAL............ Levocetirizine 5 mg............. Tablet; Oral..... Chattem Sanofi.
Dihydrochloride.
NDA 022106........ DORIBAX.......... Doripenem........ 250 mg/Vial; 500 Injectable; Shionogi, Inc.
mg/Vial. Intravenous
Infusion.
NDA 022129........ ULESFIA.......... Benzyl Alcohol... 5%............... Lotion; Topical.. Shionogi, Inc.
NDA 022157........ XYZAL............ Levocetirizine 2.5 mg/5 mL...... Solution; Oral... Chattem Sanofi.
Dihydrochloride.
NDA 022321........ EMBEDA........... Morphine Sulfate; 20 mg, 0.8 mg; 30 Capsule, Extended Alpharma Pharms.
Naltrexone mg, 1.2 mg; 50 Release; Oral.
Hydrochloride. mg, 2 mg; 60 mg,
2.4 mg; 80 mg,
3.2 mg; 100 mg,
4 mg.
NDA 050261........ DECLOMYCIN....... Demeclocycline 75 mg; 150 mg; Tablet; Oral..... Corepharma.
Hydrochloride. 300 mg.
NDA 050405........ KEFLEX........... Cephalexin....... EQ 250 mg Base; Capsule; Oral.... Pragma.
EQ 500 mg Base;
EQ 750 mg Base.
NDA 050529........ PEDIAZOLE........ Erythromycin EQ 200 mg Base/5 Granule; Oral.... Ross Labs.
Ethylsuccinate; mL; EQ 600 mg
Sulfisoxazole Base/5 mL.
Acetyl.
[[Page 48486]]
ANDA 083082....... CHLOROQUINE Chloroquine 250 mg; 500 mg... Tablet; Oral..... Hikma Pharms.
PHOSPHATE. Phosphate.
NDA 204592........ ZORVOLEX......... Diclofenac....... 18 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 drug products listed are
unaffected by the discontinued marketing of the products subject to
these applications. 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: August 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17056 Filed 8-8-22; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on August 9, 2022.
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