Regulatory Updates
FDA, EMA, TGA and global regulatory developments
Regulatory Updates
Aug 30, 2026•1 min read
KPA President Kwon Highlights Legislative Push on Network Pharmacies and Professional Standards
At the Goyang Pharmacists Association’s 60th anniversary, KPA President Kwon Young‑hee outlined ongoing bills targeting warehouse‑type pharmacies, ingredient‑based prescriptions and herbal pharmacist issues, urging members to strengthen professional expertise.
Regulatory Updates
Aug 30, 2026•1 min read
Daegu Pharmacists Host 2026 Farm Fair & Mandatory Training
Pharmacists gathered at Daegu EXCO for the 2026 Daegu City Pharmacist Farm Fair and required continuing education, highlighting improved training quality and regulatory compliance.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Mylan Fentanyl Transdermal Patches (ANDA076258)
The FDA has approved Mylan Pharmaceuticals' fentanyl transdermal extended‑release patches (ANDA076258) in multiple dosage strengths for prescription use.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves OFLOXACIN OTIC (ANDA 076527) Generic Ear Drops
The FDA approved Apotex's OFLOXACIN OTIC (0.3% otic solution) under ANDA 076527, with original approval on Sep 28, 2007 and a labeling supplement on Aug 6, 2008.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANAGRELIDE (ANDA076811)
FDA has approved the generic oral capsule ANAGRELIDE under ANDA076811, covering 0.5 mg and 1 mg strengths, sponsored by Novitum Pharma and manufactured by ANI Pharmaceuticals.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ORSYTHIA (ANDA077099) Oral Tablet
FDA has approved ANDA077099 for ORSYTHIA, an oral tablet containing ethinyl estradiol 0.02 mg and levonorgestrel 0.1 mg, sponsored by PH Health.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Ranitidine Oral Syrup (ANDA077405)
The FDA has granted approval for ANDA077405, an oral Ranitidine hydrochloride syrup (15 mg/ml) manufactured by Pharmaceutical Associates, Inc., with labeling updates through 2010.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA078594 for Topical Ciclopirox Shampoo
The FDA has approved ANDA078594 for a 1% ciclopirox prescription shampoo, a topical treatment manufactured by Padagis US.
Regulatory Updates
Aug 30, 2026•1 min read
PAMIDRONATE DISODIUM Injection Products Discontinued – ANDA077703
SUN Pharma Global's ANDA077703 for injectable pamidronate disodium (30 mg and 90 mg vials) has been marked discontinued by the FDA.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA077997 for Caffeine Citrate Intravenous Solution
The FDA has granted approval for ANDA077997, an intravenous caffeine citrate solution manufactured by Fresenius Kabi USA, now listed as a prescription drug.
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Regulatory Updates
Aug 30, 2026•1 min read
FDA scientists caution against easing peptide drug regulations for compounding pharmacies
FDA internal scientists advise against loosening controls on seven peptide ingredients intended for ulcerative colitis, insomnia and obesity, citing insufficient safety data.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA078299 for Ketorolac Tromethamine Injectable Products
The FDA has approved ANDA078299 for Ketorolac Tromethamine injectable (15 mg/mL and 30 mg/mL) from Onesource Specialty, with labeling updates; both products are marked discontinued.