Regulatorische Updates

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

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

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.

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.

The FDA has approved a series of manufacturing (CMC) and labeling submissions for the discontinued oral chlorthalidone 25 mg tablet (product 001, ANDA 087292).

The FDA has approved ANDA 088371 for a cyclophosphamide injectable product (100 mg/vial) marketed by Baxter Healthcare, with multiple manufacturing and labeling submissions approved.

The FDA’s ANDA088048 for a fluocinolone acetonide 0.01% topical solution submitted by Allied is listed as discontinued.

FDA issued an approval letter for ANDA 077780 covering carvedilol oral tablets (3.125 mg, 6.25 mg, 12.5 mg, 25 mg) submitted by TARO; all listed products are marked discontinued.

The FDA has approved Teva Pharmaceuticals’ ANDA 077487 for the oral tablet formulation of FAMCICLOVIR, available in 125 mg, 250 mg and 500 mg strengths.

The FDA’s ANDA 077179 approval covers oral capsule products of amlodipine besylate combined with benazepril hydrochloride, all listed as discontinued, with labeling submissions approved in 2011 and 2016.