İş dünyası · 29.07.20222 dk okuma
Hospira, Inc., et al.; Withdrawal of Approval of 21 Abbreviated New Drug Applications; Correction
Yerel otomatik çeviri · Kaynağın orijinal dili
Özet
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on May 20, 2022. The document announced the withdrawal of approval (as of June 21, 2022) of 21 abbreviated new drug applications (ANDAs) from multiple applicants. The document indicated that FDA was withdrawing approval of the following ANDAs after receiving withdrawal requests from Bionpharma Inc., 600 Alexander Rd., Suite 2-4B, Princeton, NJ 08540: ANDA 065301, Cefadroxil Tablets, Equivalent to (EQ) 1 gram (g) base; ANDA 065307, Cefadroxil Oral Suspension, EQ 250 milligrams (mg) base/5 milliliters (mL) and EQ 500 mg base/5 mL; ANDA 065309, Cefadroxil Capsules, EQ 500 mg base; ANDA 065326, Cephalexin Oral Suspension, EQ 125 mg base/5 mL and EQ 250 mg base/5 mL; from Sunny Pharmtech Inc., 175 SW 166th Ave., Pembroke Pines, FL 33027: ANDA 203581, Glyburide Tablets, 1.25 mg, 2.5 mg, and 5 mg; and from Unicorn Pharmaceuticals, 5 Links Circle, Durham, NC, 27707: ANDA 204137, Omeprazole and Sodium Bicarbonate Capsules, 20 mg; 1.1 g. Before FDA withdrew the approval of these ANDAs, Bionpharma Inc., Sunny Pharmtech Inc., and Unicorn Pharmaceuticals informed FDA that they did not want the ap