Regulatorische Updates

FDA granted approval for NDA 211281, covering Braintree Labs' PIZENSY oral lactitol solution, with original approval in Feb 2020 and a labeling supplement in Aug 2021.

Medtronic logged 15 complaints about incompatible leads or extensions causing surgical delays, but found no performance issues.

Medtronic logged 15 complaints from Jan 2020 to Aug 2026 involving incompatible leads or extensions, causing surgery delays or replacements, but found no device performance issues.

Scilex Pharmaceuticals' GLOPERBA, an oral colchicine solution (0.6 mg/5 mL), received FDA approval under NDA 210942, with supplemental updates in 2021 and 2024.

The FDA's recent ANDA 210602 approval includes a range of ibuprofen oral suspension products, covering dye‑free, kosher, and flavored versions for OTC use.

The FDA has approved ANDA210245 submitted by MSN for generic pomalidomide capsules in 2 mg, 3 mg, and 4 mg strengths.

The FDA has approved ANDA209591 for a prescription oral tablet combining amlodipine besylate and olmesartan medoxomil, sponsored by Hetero Labs.

Pharmobedient received FDA approval (ANDA209932) for its magnesium sulfate 5% injection in a plastic container, designated as a prescription product.

The FDA approved ANDA209242 for Camber’s prescription oral tablet combining olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide in multiple strengths.

The FDA has approved application ANDA208867 for 50 mg oral tablets of propylthiouracil, manufactured by Macleods Pharmaceuticals. The labeling submission was approved on June 26 2024.

The FDA has approved the prescription inhalation product NITROGEN, NF (NDA212315), a medical gas for respiratory use, sponsored by Universal Industrial Gases, Inc.

The FDA granted approval for artesunate 110 mg/vial for intravenous use under NDA 213036, an orphan-designated new molecular entity, with labeling updates through 2025.