AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 36 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of July 26, 2021.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 062142 | Doxycycline Hyclate Capsules, Equivalent to (EQ) 50 milligrams (mg) base and EQ 200 mg base | Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Building A, Parsippany, NJ 07054. |
| ANDA 062497 | Doxycycline Hyclate Capsules, EQ 50 mg base and EQ 100 mg base | Teva Pharmaceuticals USA, Inc. 400 Interpace Pkwy., Building A, Parsippany, NJ 07054. |
| ANDA 065152 | Cephalexin Capsules, EQ 250 mg base and EQ 500 mg base | Yung Shin Pharmaceutical Ind. Co. Ltd., authorized U.S. agent, Carlsbad Technology, Inc./Simon Law, 5922 Farnsworth Ct., Suite 101, Carlsbad, CA 92008. |
| ANDA 070550 | Propranolol Hydrochloride (HCl) Tablets, 40 mg | Watson Laboratories, Inc. |
| ANDA 070551 | Propranolol HCl Tablets, 80 mg | Do. |
| ANDA 070943 | Oxazepam Capsules, 10 mg | IVAX Pharmaceuticals Inc. (an indirect wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Building A, Parsippany, NJ 07054. |
| ANDA 070945 | Oxazepam Capsules, 30 mg | Do. |
| ANDA 071446 | Temazepam Capsules, 15 mg | Watson Laboratories, Inc. |
| ANDA 071447 | Temazepam Capsules, 30 mg | Do. |
| ANDA 072952 | Oxazepam Capsules, 10 mg | Do. |
| ANDA 073092 | Baclofen Tablets, 10 mg | Do. |
| ANDA 074400 | Diflunisal Tablets, 250 mg and 500 mg | Do. |
| ANDA 074432 | Diclofenac Sodium Delayed Release Tablets, 50 mg and 75 mg | Pliva, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Building A, Parsippany, NJ 07054. |
| ANDA 074460 | Piroxicam Capsules, 10 mg and 20 mg | Watson Laboratories, Inc. |
| ANDA 074585 | Indapamide Tablets, 1.25 mg and 2.5 mg | Do. |
| ANDA 074698 | Baclofen Tablets, 10 mg and 20 mg | Do. |
| ANDA 074711 | Mexiletine HCl Capsules, 150 mg, 200 mg and 250 mg | Do. |
| ANDA 074723 | Diclofenac Sodium Delayed Release Tablets, 50 mg | Teva Pharmaceuticals USA, Inc. |
| ANDA 074852 | Diltiazem HCl Extended Release Capsules, 120 mg, 180 mg, and 240 mg | Actavis Laboratories FL, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Building A, Parsippany, NJ 07054. |
| ANDA 074865 | Mexiletine HCl Capsules, 150 mg, 200 mg, and 250 mg | Watson Laboratories, Inc. |
| ANDA 074870 | Acyclovir Tablets, 400 mg and 800 mg | Actavis Elizabeth LLC (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Building A, Parsippany, NJ 07054. |
| ANDA 075101 | Acyclovir Capsules, 200 mg | Watson Laboratories, Inc. |
| ANDA 076022 | Fluoxetine HCl Capsules, EQ 10 mg base and EQ 20 mg base | Carlsbad Technology, Inc., 5922 Farnsworth Ct., Carlsbad, CA 92008. |
| ANDA 078345 | Prednisolone Sodium Phosphate Solution, EQ 15 mg base/5 milliliters (mL) | Amneal Pharmaceuticals, 85 Adams Ave., Hauppauge, NY 11788. |
| ANDA 080521 | Isoniazid Tablets, 300 mg | Watson Laboratories, Inc. |
| ANDA 086537 | Nitroglycerin Controlled-Release Capsules, 6.5 mg | Lumara Health, Inc., 1100 Winter St., Suite 3000, Waltham, MA 02451. |
| ANDA 086889 | Disulfiram Tablets, 250 mg | Watson Laboratories, Inc. |
| ANDA 086890 | Disulfiram Tablets, 500 mg | Watson Laboratories, Inc. |
| ANDA 087975 | Nitroglycerin Controlled-Release Capsules, 2.5 mg | Sandoz Inc., 100 College Rd. West, Princeton, NJ 08540. |
| ANDA 087976 | Nitroglycerin Controlled-Release Capsules, 6.5 mg | Do. |
| ANDA 088509 | Nitroglycerin Controlled-Release Capsules, 9 mg | Do. |
| ANDA 090833 | Carbidopa/Levodopa and Entacapone Tablets, 18.75 mg/200 mg/75 mg, 25 mg/200 mg/100 mg, 31.25 mg/200 mg/125 mg, 37.5 mg/200 mg/150 mg, and 50 mg/200 mg/200 mg | Morton Grove Pharmaceuticals Inc./Wockhardt USA LLC., 6451 Main St., Morton Grove, IL 60053. |
| ANDA 200771 | Irinotecan HCl Injection, 40 mg/2 mL (20 mg/mL) and 100 mg/5 mL (20 mg/mL) | Heritage Pharmaceuticals Inc. d/b/a/Avet Pharmaceuticals Inc. U.S. Agent for Emcure Pharmaceuticals Limited, One Tower Center Blvd., East Brunswick, NJ 08816. |
| ANDA 202063 | Gemcitabine HCl for Injection, EQ 200 mg base/vial; EQ 1 gram base/vial | Do. |
| ANDA 204437 | Sodium Fluoride 18 Injection, 10-200 millicurie (mCi)/mL | UCSF Radiopharmaceutical Facility, 185 Berry St., Suite 350, San Francisco, CA 94107. |
| ANDA 208444 | Choline C-11 Injection, 4-33.1 mCi/mL | Do. |
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of July 26, 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 July 26, 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: June 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13593 Filed 6-24-21; 8:45 am]
BILLING CODE 4164-01-P