Rules and Regulations. Notice

Agency: Food and Drug Administration, HHS
Action: Notice
Citation: FR Doc. 2021-04520 · Docket No. FDA-2021-N-0033

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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of April 5, 2021.

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 Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of April 5, 2021. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table.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. [FR Doc. 2021-04520 Filed 3-4-21; 8:45 am]