87 FR 152 pgs. 48484-48486 - Determination That AVC (Sulfanilamide) Vaginal Cream, 15%, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Type: NOTICEVolume: 87Number: 152Pages: 48484 - 48486
Pages: 48484, 48485, 48486Docket number: [Docket No. FDA-2022-N-1694]
FR document: [FR Doc. 2022-17056 Filed 8-8-22; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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Determination That AVC (Sulfanilamide) Vaginal Cream, 15%, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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.
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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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, Stacy.Kane@fda.hhs.gov.
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 §?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.
[top] FDA has become aware that the drug products listed in the table are no longer being marketed.
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| Application No. | Drug name | Active 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; Topical | Chattem, Inc. |
| NDA 008816 | XYLOCAINE | Lidocaine Hydrochloride | 2% | Jelly; Topical | Akorn. |
| 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 Gluconate | 324 mg | Tablet, Extended Release; Oral | Bayer Healthcare. |
| NDA 017386 | ZAROXOLYN | Metolazone | 2.5 mg; 5 mg; 10 mg | Tablet; Oral | Lannett Co., Inc. |
| NDA 017531 | TIGAN | Trimethobenzamide Hydrochloride | 300 mg | Capsule; Oral | King Pharms LLC. |
| NDA 018081 | DEPAKENE | Valproic Acid | 250 mg | Capsule; Oral | AbbVie Inc. |
| NDA 018281 | TEGRETOL | Carbamazepine | 100 mg | Tablet, Chewable; Oral | Novartis. |
| NDA 018303 | LOPRESSOR HCT | Hydrochlorothiazide; Metoprolol Tartrate | 25mg; 100mg | Tablet; Oral | Validus Pharms. |
| NDA 018878 | INDOCIN | Indomethacin Sodium | EQ 1 mg Base/Vial | Injectable; Injection | Recordati Rare Diseases. |
| NDA 019404 | OCUFEN | Flurbiprofen Sodium | 0.03% | Solution/Drops; Ophthalmic | Allergan. |
| NDA 019661 | CYTOVENE | Ganciclovir Sodium | EQ 500 mg Base/Vial | Injectable; Injection | Cheplapharm. |
| NDA 019697 | ORTHO TRI-CYCLEN | Ethinyl Estradiol; Norgestimate | 0.035 mg, 0.035 mg, 0.035 mg; 0.18 mg, 0.215 mg, 0.25 mg | Tablet; Oral | Janssen Pharms. |
| NDA 019766 | ZOCOR | Simvastatin | 80 mg | Tablet; Oral | Organon. |
| NDA 019814 | BETAGAN | Levobunolol Hydrochloride | 0.25% | Solution/Drops; Ophthalmic | Allergan. |
| NDA 019856 | SINEMET CR | Carbidopa; Levodopa | 25 mg, 100 mg; 50 mg, 200 mg | Tablet, Extended Release; Oral | Organon. |
| NDA 019907 | OPTIPRANOLOL | Metipranolol Hydrochloride | 0.3% | Solution/Drops; Ophthalmic | Bausch and Lomb. |
| NDA 019968 | ULTRAVATE | Halobetasol Propionate | 0.05% | Ointment; Topical | Sun Pharm Inds. Inc. |
| NDA 020010 | LOTRISONE | Betamethasone Dipropionate; Clotrimazole | EQ 0.05% Base; 1% | Lotion; Topical | Merck Sharp Dohme. |
| NDA 020381 | NIASPAN | Niacin | 500 mg; 750 mg; 1g | Tablet, Extended Release; Oral | AbbVie Inc. |
| NDA 020412 | ZERIT | Stavudine | 15 mg; 20 mg; 30 mg; 40 mg | Capsule; Oral | Bristol Myers Squibb. |
| NDA 020509 | GEMZAR | Gemcitabine Hydrochloride | EQ 200 mg Base/Vial; 1 Gram (g) Base/Vial | Injectable; Injection | Lilly. |
| NDA 020593 | DEPACON | Valproate Sodium | 100 mg Base/Milliliter (mL) | Injectable; Injection | AbbVie Inc. |
| NDA 020615 | DURACLON | Clonidine Hydrochloride | 5 mg/10 mL (0.5 mg/mL) | Injectable; Injection | Mylan Institutional. |
| NDA 020718 | INTEGRILIN | Eptifibatide | 2 mg/mL; 75 mg/100 mL | Injectable; Injection | Merck Sharp Dohme. |
| NDA 021005 | SOLARAZE | Diclofenac Sodium | 3% | Gel; Topical | Fougera Pharms. |
| NDA 021085 | AVELOX | Moxifloxacin Hydrochloride | EQ 400 mg Base | Tablet; Oral | Bayer Healthcare. |
| NDA 021183 | VIDEX EC | Didanosine | 125 mg; 200 mg; 250 mg; 400 mg | Capsule, Delayed Release Pellets; Oral | Bristol Myers Squibb. |
| NDA 021241 | ORTHO TRI-CYCLEN LO | Ethinyl Estradiol; Norgestimate | 0.025 mg, 0.025 mg, 0.025 mg; 0.18 mg, 0.215 mg, 0.25 mg | Tablet; Oral-28 | Janssen Pharms. |
| NDA 021300 | CLARINEX | Desloratadine | 0.5 mg/mL | Solution; Oral | Merck Sharp Dohme. |
| NDA 021312 | CLARINEX | Desloratadine | 2.5 mg; 5 mg | Tablet, Orally Disintegrating; Oral | Organon. |
| NDA 021372 | ALOXI | Palonosetron Hydrochloride | EQ 0.25 mg Base/5 mL (EQ 0.05 mg Base/mL); EQ 0.075 mg Base/1.5 mL (EQ 0.05 mg Base/mL) | Injectable; Intravenous | Helsinn Healthcare. |
| NDA 021444 | RISPERDAL | Risperidone | 0.5 mg; 1 mg; 2 mg; 3 mg; 4 mg | Tablet, Orally Disintegrating; Oral | Janssen Pharms. |
| NDA 021455 | BONIVA | Ibandronate Sodium | EQ 150 mg Base | Tablet; Oral | Hoffmann La Roche. |
| NDA 021605 | CLARINEX D 24 HOUR | Desloratadine; Pseudoephedrine Sulfate | 5 mg; 240 mg | Tablet, Extended Release; Oral | Organon. |
| NDA 021858 | BONIVA | Ibandronate Sodium | EQ 3 mg Base/3 mL | Injectable; Intravenous | Hoffmann La Roche. |
| NDA 021860 | SARAFEM | Fluoxetine Hydrochloride | EQ 10 mg Base; EQ 20 mg Base | Tablet; Oral | Allergan. |
| NDA 021956 | DUTOPROL | Hydrochlorothiazide; Metoprolol Succinate | 12.5 mg; EQ 25 mg Tartrate; 12.5 mg: EQ 50 mg Tartrate; 12.5 mg; EQ 100 mg Tartrate | Tablet, Extended Release; Oral | Concordia. |
| NDA 022064 | XYZAL | Levocetirizine Dihydrochloride | 5 mg | Tablet; Oral | Chattem Sanofi. |
| NDA 022106 | DORIBAX | Doripenem | 250 mg/Vial; 500 mg/Vial | Injectable; Intravenous Infusion | Shionogi, Inc. |
| NDA 022129 | ULESFIA | Benzyl Alcohol | 5% | Lotion; Topical | Shionogi, Inc. |
| NDA 022157 | XYZAL | Levocetirizine Dihydrochloride | 2.5 mg/5 mL | Solution; Oral | Chattem Sanofi. |
| NDA 022321 | EMBEDA | Morphine Sulfate; Naltrexone Hydrochloride | 20 mg, 0.8 mg; 30 mg, 1.2 mg; 50 mg, 2 mg; 60 mg, 2.4 mg; 80 mg, 3.2 mg; 100 mg, 4 mg | Capsule, Extended Release; Oral | Alpharma Pharms. |
| NDA 050261 | DECLOMYCIN | Demeclocycline Hydrochloride | 75 mg; 150 mg; 300 mg | Tablet; Oral | Corepharma. |
| NDA 050405 | KEFLEX | Cephalexin | EQ 250 mg Base; EQ 500 mg Base; EQ 750 mg Base | Capsule; Oral | Pragma. |
| NDA 050529 | PEDIAZOLE | Erythromycin Ethylsuccinate; Sulfisoxazole Acetyl | EQ 200 mg Base/5 mL; EQ 600 mg Base/5 mL | Granule; Oral | Ross Labs. |
| ANDA 083082 | CHLOROQUINE PHOSPHATE | Chloroquine Phosphate | 250 mg; 500 mg | Tablet; Oral | Hikma Pharms. |
| NDA 204592 | ZORVOLEX | Diclofenac | 18 mg | Capsule; Oral | Zyla. |
FDA has reviewed its records and, under §?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