AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 27 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
DATES:
Approval is withdrawn as of February 16, 2021.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-402-6980, Martha.Nguyen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.
| Application No. | Drug | Applicant |
|---|---|---|
| ANDA 040083 | Phentermine Hydrochloride (HCl) Capsules, 30 milligrams (mg) | TG United Inc., 16275 Aviation Loop Dr., Brooksville, FL 34604. |
| ANDA 040451 | Cyanocobalamin Injection, 1 mg/milliliters (mL) | Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL 61103. |
| ANDA 040518 | Bethanechol Chloride Tablets, 50 mg | Morton Grove Pharmaceuticals Inc./Wockhardt USA LLC, 6451 W. Main St., Morton Grove, IL 60053. |
| ANDA 040532 | Bethanechol Chloride Tablets, 5 mg | Do. |
| ANDA 060347 | Tetracycline HCl Capsules, 250 mg | Pharmacia & Upjohn Co., a subsidiary of Pfizer Inc., 235 East 42nd St., New York, NY 10017. |
| ANDA 060478 | Neomycin Sulfate Ophthalmic Ointment | Pfizer Inc., 235 East 42nd St., New York, NY 10017. |
| ANDA 065266 | Clarithromycin Tablets, 250 mg and 500 mg | Morton Grove Pharmaceuticals Inc./Wockhardt USA LLC. |
| ANDA 065281 | Doxycycline Hyclate Delayed Release Capsules, Equivalent to (EQ) 75 mg base; EQ 100 mg base | Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. |
| ANDA 075208 | Ranitidine HCl Tablets, EQ 150 mg base; EQ 300 mg base | Morton Grove Pharmaceuticals Inc./Wockhardt USA LLC. |
| ANDA 075822 | Loratadine Orally Disintegrating Tablets, 10 mg | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, 184 Liberty Corner Rd., Suite 200, Warren, NJ 07059. |
| ANDA 076760 | Ranitidine HCl Tablets, EQ 75 mg base | Morton Grove Pharmaceuticals Inc./Wockhardt USA LLC. |
| ANDA 076849 | Vinorelbine Tartrate Injection, EQ 10 mg base/mL | Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047. |
| ANDA 077432 | Carboplatin Injection, 50 mg/5 mL(10 mg/mL), 150 mg/15 mL (10 mg/mL), and 450 mg/45 mL (10 mg/mL) | Do. |
| ANDA 078500 | Amlodipine Besylate Tablets, EQ 2.5 mg base; EQ 5 mg base; EQ 10 mg base | Morton Grove Pharmaceuticals Inc./Wockhardt USA LLC. |
| ANDA 084041 | Chlordiazepoxide HCl Capsules, 10 mg | Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr., Maple Grove, MN 55369. |
| ANDA 084678 | Chlordiazepoxide HCl Capsules, 5 mg | Do. |
| ANDA 084679 | Chlordiazepoxide HCl Capsules, 25 mg | Do. |
| ANDA 088508 | Homatropine Methylbromide; Hydrocodone Bitartrate Tablets, 1.5 mg; 5 mg | King Pharmaceuticals Research and Development, LLC, 4000 Centregreen Way, Suite 300, Cary, NC 27513. |
| ANDA 089953 | Thioridazine HCl Tablets, 10 mg, 25 mg, 50 mg, and 100 mg | Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540. |
| ANDA 090094 | Didanosine Delayed Release Capsules, 125 mg, 200 mg, 250 mg, and 400 mg | Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Rd., East Windsor, NJ 08520. |
| ANDA 090394 | Iopamidol Injection, 61% and 76% | Sanochemia Corporation USA, 9201 University City Blvd., c/o Countervail Corp., Charlotte, NC 08876. |
| ANDA 091302 | Fludrocortisone Acetate Tablets, 0.1 mg | Hikma Pharmaceuticals USA Inc., 1809 Wilson Rd., Columbus, OH 43228. |
| ANDA 203959 | Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, and 250 mg | Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 425 Privet Rd., Horsham, PA 19044. |
| ANDA 204243 | Indomethacin Extended Release Capsules, 75 mg | Aurobindo Pharma USA, Inc. |
| ANDA 206061 | Pravastatin Sodium Tablets, 20 mg, 40 mg, and 80 mg | Hisun Pharmaceuticals USA, Inc., 200 Crossing Blvd., 2nd Floor, Bridgewater, NJ 08807. |
| ANDA 206857 | Tiagabine HCl Tablets, 2 mg, 4 mg, 12 mg, and 16 mg | Wilshire Pharmaceuticals, Inc., 6 Concourse Pkwy., Suite 1800, Atlanta, GA 30328. |
| ANDA 209076 | Ibuprofen Tablets, 200 mg | Ultra Tab Laboratories, Inc., 50 Toc Dr., Highland, NY 12528. |
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of February 16, 2021. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on February 16, 2021 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.
Dated: January 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-00833 Filed 1-14-21; 8:45 am]
BILLING CODE 4164-01-P