Regulatorische Updates

The FDA has approved labeling for generic levetiracetam tablets, 250 mg to 1 g, from BluePoint Laboratories and Aurobindo Pharma.

The FDA’s ANDA 087722 for LORTAB (acetaminophen 500 mg/hydrocodone 5 mg oral tablet) includes a series of approved manufacturing and labeling submissions from 1984 to 1999; the product is now discontinued.

FDA records show a series of approved labeling and manufacturing supplemental applications for the discontinued LINDANE 1% topical lotion under ANDA 087313.

The FDA record shows SCANDONEST L injectable, containing levonordefrin and mepivacaine, has a discontinued marketing status and a history of approved labeling and manufacturing submissions dating from 1984 to 2018.

The FDA’s ANDA088071 filing shows that DEXAIR ophthalmic ointment, containing 0.05% dexamethasone sodium phosphate, is marked discontinued by sponsor PharmaFair.

The FDA has approved ANDA077507, a generic oral tablet combining glipizide and metformin hydrochloride in three strengths, submitted by EPIC PHARMA LLC.

The FDA’s ANDA 077198 for alprazolam extended‑release tablets submitted by Actavis Labs FL Inc shows all listed products as discontinued.

The FDA has approved the ANDA076900 for Atenolol tablets (25 mg, 50 mg, 100 mg) manufactured by Zydus Lifesciences and Zydus Pharmaceuticals USA.

The FDA granted approval for ANDA076620 on Oct 15, 2004, covering three oral fosinopril sodium tablet strengths submitted by Actavis Labs, all currently listed as discontinued.

The FDA has approved Teva Pharmaceuticals’ ANDA 076346 for torsemide oral tablets in 5 mg, 10 mg, 20 mg and 100 mg strengths, prescription‑only.

The FDA approved ANDA077797 for prescription oral tablets of Cycbenzaprine Hydrochloride, 5 mg and 10 mg, manufactured by Solco Healthcare U.S., LLC and sponsored by Prinston Inc.

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