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

요약

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of March 5, 2021. The document announced the withdrawal of approval of seven abbreviated new drug applications (ANDAs) from multiple applicants as of April 5, 2021. The document indicated that FDA was withdrawing approval of the following five ANDAs, after receiving a withdrawal request from Neopharma, Inc., 211 College Road East, Suite 101, Princeton, NJ 08540: ANDA 078383, Pioglitazone Hydrochloride (HCl) Tablets, Equivalent to (EQ) 15 milligrams (mg) base, EQ 30 mg base, and EQ 45 mg base; ANDA 078953, Irinotecan HCl Injection, 40 mg/2 milliliters (mL) (20 mg/mL) and 100 mg/5 mL (20 mg/mL); ANDA 079049, Alendronate Sodium Tablets, EQ 5 mg base, EQ 10 mg base, EQ 35 mg base, and EQ 70 mg base; ANDA 090732, Anastrozole Tablets, 1 mg; and ANDA 203161, Irbesartan Tablets, 75 mg, 150 mg, and 300 mg. Before FDA withdrew the approval of these ANDAs, Neopharma, Inc., informed FDA that it did not want the approval of the ANDAs withdrawn. Because Neopharma, Inc., timely requested that approval of these ANDAs not be withdrawn, the approval of ANDAs 078383, 078953, 079049, 090732, and 203161