2021-04520. Morton Grove Pharmaceuticals Inc. et al.; Withdrawal of Approval of Seven Abbreviated New Drug Applications

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is withdrawing approval of seven 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of April 5, 2021.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, [e-mail].

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 065428	Cefprozil Tablets, 250 milligrams (mg) and 500 mg	Morton Grove Pharmaceuticals Inc./Wockhardt USA LLC., 6451 Main St., Morton Grove, IL 60053.
ANDA 077699	Mefloquine Hydrochloride (HCl) Tablets, 250 mg	Hikma Pharmaceuticals USA Inc., 1809 Wilson Rd., Columbus, OH 43228.
ANDA 078383	Pioglitazone HCl Tablets, Equivalent to (EQ) 15 mg base; EQ 30 mg base; EQ 45 mg base	Neopharma Inc., 211 College Road East, Suite 101, Princeton, NJ 08540.
ANDA 078953	Irinotecan HCl Injection, 40 mg/2 milliliters (mL) (20 mg/mL) and 100 mg/5 mL (20 mg/mL)	Do.
ANDA 079049	Alendronate Sodium Tablets, EQ 5 mg base; EQ 10 mg base; EQ 35 mg base; EQ 70 mg base	Do.
ANDA 090732	Anastrozole Tablets, 1 mg	Do.
ANDA 203161	Irbesartan Tablets, 75 mg, 150 mg, and 300 mg	Do.

Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of April 5, 2021. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table.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 April 5, 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: February 26, 2021.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.