Regulatorische Updates

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

The FDA has approved preservative‑free lidocaine hydrochloride injectable products (2% and 4%) under NDA 017584, manufactured by Fresenius Kabi USA.

ALF Bio has received ISO 45001 occupational health and safety certification, reinforcing its manufacturing and quality competitiveness in the medical aesthetic sector.

The FDA has approved the oral syrup formulation of ethosuximide (250 mg/5 ml) under ANDA 081306, with multiple manufacturing and labeling submissions listed.

The FDA has approved Mylan’s supplemental application (ANDA088332) for a 10 mg oral tablet of thioridazine hydrochloride, though the product is 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.

FDA approved labeling and manufacturing submissions for ANDA081008 covering the oral tablet STRIFON FORTE DSC (500 mg chlorzoxazone) by Fern Dale Labs; the product is now discontinued.

FDA has approved multiple manufacturing and labeling submissions for discontinued chlorpromazine hydrochloride tablets, noting the discontinuations were not due to safety or effectiveness concerns.

The FDA approved labeling for the discontinued injectable PLASMA‑LYTE 56 and Dextrose 5% product, with multiple manufacturing submissions approved since 1986.

The FDA approved ANDA081069 for an oral capsule containing 5 mg hydrocodeine bitartrate and 500 mg acetaminophen, sponsored by Mikart. The product is listed as discontinued.

The FDA has approved a series of supplemental labeling and manufacturing submissions for the discontinued oral tablet Phentermine Hydrochloride (37.5 mg) under ANDA 088596.

The FDA’s NDA006920 for Lederle’s oral drug Triple Sulfas includes two discontinued formulations—a suspension and a tablet—both containing trisulfapyrimidines, sulfamerazine, and sulfamethazine.