Regulatorische Updates

The FDA approved ANDA077797 for prescription oral tablets of Cycbenzaprine Hydrochloride, 5 mg and 10 mg, manufactured by Solco Healthcare U.S., LLC and sponsored by Prinston Inc.

The FDA approved Diprosone lotion, a topical betamethasone dipropionate product (0.05% base) under NDA 017781. It is listed as discontinued but not withdrawn for safety reasons.

The FDA has approved ANDA078395 for a 2% Dorzolamide Hydrochloride ophthalmic solution marketed by Advagen Pharma Ltd., with Rubicon Research as sponsor.

The FDA has approved labeling submissions for Teva Pharm’s discontinued levetiracetam tablets (250 mg, 500 mg, 750 mg, 1 g) under ANDA078101.

Fierce Pharma’s H2 2026 Regulatory Tracker logs progress of existing products, noting geographic expansions and new indications, even when updates aren’t full stories.

FDA inspectors issued a Form 483 to Sanofi’s Genzyme Ireland after a 2026 site visit, prompting additional regulatory reprimand.

Draeger reports observed hose cracks in VentStar Resus Neo and Resuscitaire; no confirmed patient harm yet.

Health Canada has issued a recall of Twins Herbal’s Idakole and Pelorie liquid products, which were sold without market authorization and contain the undeclared prescription drug sildenafil. Consumers should stop use and contact a healthcare provider.

Draeger reports users have found visible hose cracks in VentStar® Resus Neo and Resuscitaire devices before use; no health impacts reported but risk cannot be excluded.

The Ministry of Health and Welfare released draft amendments to coverage rules for antiepileptic, dry‑eye, autoimmune and respiratory drugs, effective July 1, with comments accepted until the 22nd.

The Ministry of Health and Welfare’s Abnormal and Fake Treatment Investigation Unit announced on the 18th that it will immediately begin on‑site investigations of suspected illegal practices such as patient recruitment, pay‑back schemes, and high‑cost non‑covered treatments aimed at cancer patients.

FDA’s database shows ANDA085199 for a discontinued 35 mg oral tablet of Phendimetrazine Tartrate submitted by PVT FORM.