規制動向

FDA records show that MPP Pharma's ANDA076486 for two oral enalapril maleate/hydrochlorothiazide tablets received multiple labeling approvals, but both products are listed as discontinued.

FDA records show Warner Chilcott's Duraquin oral extended‑release tablet (quinine gluconate 330 mg) is discontinued under application NDA017917.

The FDA has approved a prescription topical lotion containing 12% ammonium lactate, submitted under ANDA 076216 by Sun Pharma Canada.

The FDA granted approval for NDA018140, authorizing Lorazepam injectable (brand name ATIVAN) from Hikma Pharmaceuticals USA and Civica, Inc.

The FDA has approved ANDA 084282 for Dexamethasone Sodium Phosphate injectable, a prescription drug manufactured by Hikma and Civica with multiple NDC listings.

The FDA has discontinued two injectable testosterone enanthate products from Watson Labs, listed under ANDA083667.

Experts highlight need for pharmacy-based pharmacovigilance for over‑the‑counter medicines due to hidden adverse events.

The FDA approved ANDA080713 for Watson Labs' oral tablet TripeLennaMine Hydrochloride 50 mg, now listed as discontinued, with a history of multiple supplemental approvals.

FDA approved three manufacturing supplement submissions for Isoniazid tablets (50 mg and 100 mg) under ANDA080132; both products are listed as discontinued.

Bell Pharma’s oral tablet of chlorpheniramine maleate (4 mg) under ANDA083062 has been marked as discontinued.

The FDA has approved application ANDA078979 for the oral delayed‑release capsule of DIVALPROEX SODIUM, manufactured by NorthStar Rx LLC and Dr. Reddy's Laboratories Ltd.

The FDA's ANDA087695 filing for FOLEX injectable methotrexate (25 mg, 50 mg, 100 mg) shows all three products are listed as discontinued.