Regulatorische Updates

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

The FDA has approved labeling for Chartwell RX's fluticasone propionate nasal spray (ANDA078492), a prescription nasal spray.

The FDA has approved ANDA084590 for Sodium Pentobarbital 100 mg oral capsules by sponsor Anabolic; the product is listed as discontinued.

FDA records show approved manufacturing and labeling submissions for the discontinued oral tablet HYDROCODONE BITARTRATE AND ACETAMINOPHEN (500 mg/7.5 mg).

The FDA has listed the oral Nitrofurantoin 100 mg tablet (product 002) from Whiteworth Town PLsn as discontinued under ANDA 084085.

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

The FDA has approved ANDA 087562 submitted by IDT Australia Ltd for a 50 mg oral tablet of dipyridamole, originally listed as discontinued.

The FDA record (ANDA083453) shows Halsey’s oral Niacin 500 mg tablet (product 001) is marked discontinued and is not a reference drug.

FDA records indicate that PROCAN SR, an oral extended‑release tablet containing 250 mg procaineamide hydrochloride, has been discontinued. Sponsor Parke Davis filed multiple labeling submissions.

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.

FDA has approved six oral tablet strengths of risperidone (0.25 mg to 4 mg) as prescription products, with labeling updates from 2008 to 2023.

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