Regulatorische Updates

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.

SUN PHARM INDS LTD's ANDA076786 for oral Donepezil Hydrochloride tablets (5 mg and 10 mg) has been approved by the FDA, with both products listed as discontinued.

The FDA has approved ANDA 076504 for a prescription fluticasone propionate nasal spray, manufactured by Hikma Pharmaceuticals and Golden State Medical Supply.

Mallinckrodt Inc. received FDA approval for its original Abbreviated New Drug Application (ANDA) 078273 on September 19, 2007.

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

FDA grants approval for ANDA077676, a prescription ciclopirox olamine 0.77% topical suspension from Padagis Israel Pharmaceuticals.

The FDA has approved several manufacturing (CMC) supplement submissions for Sandoz’s Orphenadrine Citrate extended‑release tablet (ANDA 085046), which is currently listed as discontinued.

The FDA’s ANDA084559 filing shows PANRAY’s oral elixir THEOLIXIR, containing THEOPHYLLINE 80MG/15ML, is listed as discontinued.

FDA approved Sandoz's ANDA090137 covering two Irinotecan Hydrochloride injectable products, both listed with discontinued marketing status.

The FDA approved ANDA089615 for ISOETHARINE HYDROCHLORIDE inhalation solution (0.125%) by AstraZeneca. The product is listed as discontinued.

The FDA approved the abbreviated new drug application ANDA079164 for Flecainide Acetate tablets (50 mg, 100 mg, 150 mg) from Chartwell RX, though the products are currently listed as discontinued.