Regulatorische Updates

The FDA has approved application ANDA078127 for an oral ondansetron solution (4 mg/5 mL) marketed by PAI Holdings, LLC dba PAI Pharma.

The FDA has approved ANDA076920 for Levetiracetam tablets (250 mg, 500 mg, 750 mg) manufactured by Dr. Reddy's Laboratories and sponsored by Pharmazone.

The FDA approved ANDA 076368 for two extended‑release potassium chloride tablets (10 mEq and 20 mEq) marketed by AdaRe Pharm and manufactured by Sun Pharmaceutical.

The FDA has approved the ANDA216294 application for a calcitonin salmon injectable (200 IU/mL) manufactured by Amneal Pharmaceuticals.

The FDA has approved ANDA215856 for a 10 mg/mL furosemide injectable, manufactured by Devatis Inc. and sponsored by Saba Ilac Sanayive.

The FDA has approved Ajanta Pharma’s oral varenicline tartrate tablets (0.5 mg and 1 mg equivalents) under ANDA213019, marking a new prescription option.

The FDA has approved ANDA212645 for paroxetine extended‑release tablets (12.5 mg, 25 mg, 37.5 mg) marketed by Cadila Pharm Ltd and Modavar Pharmaceuticals.

The FDA’s NDA215007 for NexAir’s carbon dioxide inhalation gas (USP) is listed with approval status AP, detailing route, dosage form, and NDC codes.

The FDA approved Strides Pharma's minocycline hydrochloride oral tablets (50 mg, 75 mg, 100 mg) under ANDA 065131, confirming prescription status.

The FDA has approved ANDA203834 for prescription oral acyclovir tablets (400 mg and 800 mg) manufactured by Camber Pharmaceuticals and sponsored by Hetero Labs.

The FDA granted approval for NDA 017830, authorizing the prescription oral tablet Lodosyn (carbidopa) from Bausch Health US and Oceanside Pharmaceuticals.

The FDA granted approval for Bausch & Lomb's OFLOXACIN 0.3% ophthalmic solution (prescription) under ANDA 076622, originally approved in May 2004 with a labeling update in 2020.