Regulatory Updates

The FDA approved ANDA076721 for Megestrol Acetate oral suspension (40 mg/mL) submitted by PHARMOBEDIENT and manufactured by Xttrium Laboratories.

FDA approved ANDA076440 for ANI Pharmaceuticals' risperidone oral solution (1 mg/mL), a prescription atypical antipsychotic, with recent labeling updates in July 2024.

The FDA has approved ANDA078203 for Lorazepam tablets (0.5 mg, 1 mg, 2 mg) manufactured by Leading Pharma, LLC.

The FDA database shows ANDA080491 for a 5 mg oral tablet of Prednisone submitted by Elkins Sinn, currently marked as discontinued.

FDA granted approval for ANDA079186, a generic Dorzolamide Hydrochloride ophthalmic solution submitted by AM Regent, with original approval in 2009 and a labeling supplement in 2020.

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 approved ANDA077076 submitted by Bedford for Lorazepam injectable products (2 mg/mL and 4 mg/mL), both listed as discontinued.

The FDA granted approval for ANDA 076233, a Paclitaxel injectable (6 mg/mL) submitted by Hospira. Original approval 2002, labeling supplement 2007.

Cypress Pharm Inc.'s ZYFREL oral solution (acetaminophen 325 mg/15 mL and hydrocodone 7.5 mg/15 mL) received FDA approval under ANDA090468, with labeling supplements approved in 2016 and 2017.

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 granted approval for NDA018140, authorizing Lorazepam injectable (brand name ATIVAN) from Hikma Pharmaceuticals USA and Civica, Inc.

The FDA has approved ANDA 084282 for Dexamethasone Sodium Phosphate injectable, a prescription drug manufactured by Hikma and Civica with multiple NDC listings.