Regulatory Updates

The FDA has approved ANDA 077351, covering a range of oral acid‑reducer and heartburn‑prevention products listed under various brand names.

The FDA approved Apotex's OFLOXACIN OTIC (0.3% otic solution) under ANDA 076527, with original approval on Sep 28, 2007 and a labeling supplement on Aug 6, 2008.

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 approved NESHER PHARMS' ANDA077176 for metoprolol succinate extended‑release tablets (50 mg eq). The product is listed as discontinued.

The FDA approved an ANDA (ANDA080123) for LANTRISUL oral suspension, a discontinued product containing trisulfapyrimidines, sulfamerazine, and sulfamethazine, submitted by LANNETT.

TABLICAPS has filed ANDA085207 for an oral 0.25 mg Reserpine tablet, which is listed with a discontinued marketing status.

The FDA approved ANDA 084744 on Dec 9 1975 for Meprobamate tablets (200 mg and 400 mg) marketed by Parke Davis, now listed as discontinued.

The FDA has approved ANDA078395 for a 2% Dorzolamide Hydrochloride ophthalmic solution marketed by Advagen Pharma Ltd., with Rubicon Research as sponsor.

The FDA granted approval for SUN PHARM INDUSTRIES' ANDA080699 covering oral Meprobamate tablets (200 mg and 400 mg). Multiple manufacturing and labeling submissions were approved between 1986 and 1998; the products are now discontinued.

The FDA approved ANDA080094 for the oral tablet TRIPLE SULFOID, containing trisulfapyrimidines, sulfamerazine, and sulfamethazine, though the product is listed as discontinued.

FDA approved ANDA076877 for gabapentin 600mg and 800mg oral tablets submitted by Senores Pharms; both products are listed as discontinued.

The FDA approved generic ciprofloxacin hydrochloride tablets (250 mg, 500 mg, 750 mg) under ANDA 076593, sponsored by Aiping Pharm and manufactured by Westminster Pharmaceuticals.