규제 업데이트

The FDA has approved a series of priority manufacturing (CMC) supplement submissions for the discontinued LIORESAL baclofen tablets (10 mg and 20 mg).

OCUCLEAR ophthalmic drops containing 0.025% oxyMetazoline hydrochloride have been discontinued; FDA records show a series of approved manufacturing and labeling submissions from 1986 to 2001.

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

FDA granted approval for PHOTOFRIN, a porfimer sodium injectable marketed by Pinnacle Biologics, under application NDA020451.

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.

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

FDA records show multiple manufacturing and labeling approvals for Glycine 1.5% irrigation solution (NDA 017633); the product is now discontinued.

The FDA records show original approval in 1974 and multiple supplemental approvals for the ophthalmic solution Naphazoline Hydrochloride, now listed as discontinued.

FDA records show Isopto Cetamide ophthalmic solution (15% sulfacetamide sodium) received several approved manufacturing and labeling submissions from 1971 to 2000; the product is now discontinued.

The EMA Committee on Medicinal Products for Human Use (CHMP) recommended 12 new medicines for approval and issued several biosimilar, generic, re‑examination and indication‑extension updates.

Korean Biochem Pharm received regulatory approval for two silodosin‑rosuvastatin sustained‑release tablets, expanding Korean United Pharm’s product line.