Regulatorische Updates

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.

Pharmacists gathered at Daegu EXCO for the 2026 Daegu City Pharmacist Farm Fair and required continuing education, highlighting improved training quality and regulatory compliance.

The FDA has approved Mylan Pharmaceuticals' fentanyl transdermal extended‑release patches (ANDA076258) in multiple dosage strengths for prescription use.

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.

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.

FDA has approved ANDA077099 for ORSYTHIA, an oral tablet containing ethinyl estradiol 0.02 mg and levonorgestrel 0.1 mg, sponsored by PH Health.

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.

The FDA has approved ANDA078594 for a 1% ciclopirox prescription shampoo, a topical treatment manufactured by Padagis US.

SUN Pharma Global's ANDA077703 for injectable pamidronate disodium (30 mg and 90 mg vials) has been marked discontinued by the FDA.

The FDA has granted approval for ANDA077997, an intravenous caffeine citrate solution manufactured by Fresenius Kabi USA, now listed as a prescription drug.

FDA internal scientists advise against loosening controls on seven peptide ingredients intended for ulcerative colitis, insomnia and obesity, citing insufficient safety data.

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.