Regulatorische Updates

TABLICAPS has filed ANDA084632 for an oral aminophylline 100 mg delayed‑release tablet, currently listed as discontinued.

The FDA approved ANDA077533 for the oral terbinafine tablet (brand name Terbinafine). Sponsored by Invagen Pharms, the product is now listed as discontinued.

South Korea's MFDS will prohibit pediatric prescriptions of dioctahedral smectite after finding insufficient safety data on lead content, sparking recall concerns.

FDA has approved Chartwell Rx's ANDA077831 for oral CILOSTAZOL tablets in 50 mg and 100 mg strengths, with labeling updates approved in 2016.

FDA listed approval for ANDA078132 submitted by Northstar Healthcare covering oral ibuprofen tablets (400 mg, 600 mg, 800 mg) now marked discontinued.

The FDA has granted approval for Teva Pharmaceuticals' generic carvedilol oral tablets, covering strengths from 3.125 mg to 25 mg under ANDA 076373.

The FDA approved PROGLYCEM, an oral suspension of diazoxide (50 mg/mL) from Teva Pharmaceuticals, under application NDA 017453.

The FDA has approved labeling and manufacturing submissions for ISOPAQUE 280, an injectable calcium, meglumine, and metrizoic acid product, under NDA 017506.

The FDA approved SUN Pharma Canada's ANDA077227 for a topical 0.05% halobetasol propionate cream; the product is currently listed as discontinued.

The FDA has approved ANDA078420 for Nabumetone tablets (500 mg and 750 mg) marketed by ScieGen Pharmaceuticals, adding a new oral NSAID to the prescription market.

FDA approved Hikma International Pharmaceutics' generic lithium carbonate 300 mg tablet (ANDA 078715) on Dec 28 2010, with a labeling supplement approved in 2012.

The FDA has approved ANDA079029 for oral amiodarone hydrochloride tablets (100 mg, 200 mg, 400 mg) manufactured by Zydus Lifesciences and Zydus Pharmaceuticals USA.