Regulatorische Updates

The FDA has granted labeling approval for Glenmark Pharmaceuticals’ generic carvedilol tablets (ANDA078251), available in 3.125 mg, 6.25 mg, 12.5 mg and 25 mg oral dosage forms.

The FDA has granted approval for an Abbreviated New Drug Application (ANDA) 076768 covering multiple strengths of alendronate sodium tablets, manufactured by Exelan Pharmaceuticals and Cipla USA.

The FDA granted approval (ANDA 084031) for BARR's sulfisozole 500 mg oral tablet, which is listed as discontinued. A labeling supplement was filed in 1995.

Sun Pharm Industries' quinidine sulfate tablet (200 mg) received FDA approval under ANDA081030, with manufacturing and labeling submissions approved between 1989 and 2010. The product is currently 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 approved ANDA080713 for Watson Labs' oral tablet TripeLennaMine Hydrochloride 50 mg, now listed as discontinued, with a history of multiple supplemental approvals.

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 approved application ANDA076605 for Ranbaxy’s oral gabapentin tablets (600 mg and 800 mg). Both products are currently listed as discontinued.

Sandoz's ANDA078674 for oral rosiglitazone maleate tablets (2 mg, 4 mg, 8 mg) has received tentative approval from the FDA as of March 9 2009.

FDA granted approval for ANDA214219 covering oral Triazolam tablets (0.125 mg and 0.25 mg) manufactured by Ingenus Pharmaceuticals, LLC.

The FDA has approved ANDA217961 for CARBIDOPA 25 mg oral tablets, a prescription product submitted by Regcon Holdings.

The FDA approved ANDA083784 for a 12.5 mg oral Meclizine Hydrochloride tablet submitted by IVAX Sub Teva Pharm; the product is currently listed as discontinued.