Regulatory Updates
Sep 24, 2026•1 min read
FDA approves PHOTOFRIN (Porfimer Sodium) injection – NDA020451
FDA granted approval for PHOTOFRIN, a porfimer sodium injectable marketed by Pinnacle Biologics, under application NDA020451.
Regulatory Updates
Sep 23, 2026•1 min read
FDA Approves Lidocaine Hydrochloride Injection (NDA 017584)
The FDA has approved preservative‑free lidocaine hydrochloride injectable products (2% and 4%) under NDA 017584, manufactured by Fresenius Kabi USA.
Regulatory Updates
Sep 23, 2026•1 min read
ALF Bio Secures ISO 45001 Certification to Boost Safety and Quality in Medical Aesthetic Manufacturing
ALF Bio has received ISO 45001 occupational health and safety certification, reinforcing its manufacturing and quality competitiveness in the medical aesthetic sector.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves Ethosuximide Oral Syrup (ANDA 081306)
The FDA has approved the oral syrup formulation of ethosuximide (250 mg/5 ml) under ANDA 081306, with multiple manufacturing and labeling submissions listed.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves Manufacturing Submission for Mylan’s Thioridazine Hydrochloride Tablet (ANDA088332)
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.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves Multiple Submissions for Discontinued Ophthalmic Product Isopto Cetamide
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.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA081008 for STRIFON FORTE DSC (Chlorzoxazone)
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.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Manufacturing and Labeling Submissions for Discontinued Chlorpromazine Tablets
FDA has approved multiple manufacturing and labeling submissions for discontinued chlorpromazine hydrochloride tablets, noting the discontinuations were not due to safety or effectiveness concerns.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Labeling for PLASMA‑LYTE 56 and Dextrose 5% Injection (NDA 017385)
The FDA approved labeling for the discontinued injectable PLASMA‑LYTE 56 and Dextrose 5% product, with multiple manufacturing submissions approved since 1986.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA081069 for Hydrocodeine Bitartrate and Acetaminophen Oral Capsule
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.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Multiple Supplemental Submissions for Phentermine Hydrochloride (ANDA 088596)
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.
Regulatory Updates
Sep 19, 2026•1 min read
FDA NDA006920: Lederle's Triple Sulfas Oral Products Listed as Discontinued
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.