Regulatorische Updates

The FDA issued an approval letter for Mylan Pharm Inc.’s topical ciclopirox 8% solution (ANDA 078567), though the product is listed as discontinued.

The FDA has approved application ANDA077370 for generic glimepiride tablets (1‑8 mg) manufactured by Solco Healthcare U.S., LLC and sponsored by Prinston Inc.

FDA approves ANDA 077973 for Synthon Pharm’s 50 mg oral bicalutamide tablet; labeling approved in 2009 and manufacturing in 2011.

The FDA’s ANDA077657 for lorazepam tablets (0.5 mg, 1 mg, 2 mg) lists all products as discontinued and details several supplemental labeling submissions.

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.

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.

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.

The FDA has approved ANDA210245 submitted by MSN for generic pomalidomide capsules in 2 mg, 3 mg, and 4 mg strengths.

FDA has approved an ANDA for a 1 mg oral folic acid tablet submitted by PurePac Pharm; the product is listed as discontinued.

The FDA has approved ANDA085785 for Sandoz’s oral tablet of trifluoperazine hydrochloride, a prescription drug, with multiple manufacturing and labeling approvals spanning 1982‑1999.

The FDA has approved Apotex’s generic Tizanidine Hydrochloride oral capsules (2 mg, 4 mg, 6 mg) under application ANDA078868.