Watson Laboratories, Inc. et al.; Withdrawal of Approval of 36 Abbreviated New Drug Applications
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 Ag...
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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of July 26, 2021.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.
( printed page 33719)
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
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.
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.
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.
Use this for formal legal and research references to the published document.
86 FR 33718
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Watson Laboratories, Inc. et al.; Withdrawal of Approval of 36 Abbreviated New Drug Applications,” thefederalregister.org (June 25, 2021), https://thefederalregister.org/documents/2021-13593/watson-laboratories-inc-et-al-withdrawal-of-approval-of-36-abbreviated-new-drug-applications.
21 CFR 314.150(c)
21 U.S.C. 331(a)