Regulatory Updates
FDA, EMA, TGA and global regulatory developments
Regulatory Updates
Sep 13, 2026•1 min read
FDA Lists TEVA's TRIPHED Oral Tablet as Discontinued (ANDA088630)
The FDA record for ANDA088630 shows TEVA's TRIPHED oral tablet, containing pseudoephedrine HCl 60 mg and triprolidine HCl 2.5 mg, is now marked discontinued.
Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves ANDA078598 for Ciprofloxacin Hydrochloride Ophthalmic Solution
The FDA approved ANDA078598, submitted by J Molner, for a 0.3% ciprofloxacin hydrochloride ophthalmic solution. The product is listed as discontinued.
Regulatory Updates
Sep 13, 2026•1 min read
Fougera Pharms Receives FDA Approval for CALCIPOTRIENE Topical Solution (ANDA 078305)
The FDA has approved Fougera Pharms' CALCIPOTRIENE 0.005% topical solution under ANDA 078305, a new prescription product.
Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves Cipla Esomeprazole Magnesium ANDA078003
FDA granted approval for Cipla's ANDA078003 generic esomeprazole magnesium, covering two discontinued oral capsule products.
Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves Teva Methylphenidate Hydrochloride ER Capsules (ANDA 077707)
FDA has approved Teva Pharm’s methylphenidate hydrochloride extended‑release capsules in 10 mg, 20 mg and 30 mg strengths under ANDA 077707.
Regulatory Updates
Sep 13, 2026•1 min read
Cipla ANDA 077411 for Lamivudine and Zidovudine Tablet Approved by FDA
Cipla's ANDA 077411 for a prescription tablet combining lamivudine 150 mg and zidovudine 300 mg has been approved by the FDA.
Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves ANDA 077105 for Valproic Acid Oral Syrup
FDA has approved multiple labeling supplements for the discontinued VALPROIC ACID oral syrup (ANDA 077105). Original approval dates to 2005.
Regulatory Updates
Sep 13, 2026•1 min read
Relay Protest Marks 348 Days Demanding Han‑yaksa Licensing Reform in South Korea
A relay rally in front of Seoul’s Blue House, now in its 348th day, called for clear separation of pharmacist and han‑yaksa licenses and swift resolution of longstanding issues.
Regulatory Updates
Sep 13, 2026•1 min read
Pharma Research Faces 2-Month Advertising Suspension for Rejuran Derma Hiller Por Tightening Ampoule
Pharma Research's cosmetic product 'Rejuran Derma Hiller Por Tightening Ampoule' will have its online advertising halted for two months due to potentially misleading clinical claims, per MFDS.
Regulatory Updates
Sep 12, 2026•1 min read
Opposition Grows to Pharmacy Law Amendment Requiring Employers to Provide Free Emergency Medicines
Critics argue the draft amendment imposes unnecessary duties on employers and undermines pharmacies' professional market position.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves ANDA 076815 for Diazepam Injectable
The FDA approved ANDA 076815 submitted by Parenta Pharms for a 5 mg/mL injectable diazepam product, currently listed as discontinued.
Regulatory Updates
Sep 12, 2026•1 min read
Teva Pharm’s Simvastatin Tablet ANDA 076532 Receives Tentative FDA Approval
The FDA granted tentative approval to Teva Pharm’s generic simvastatin tablets (5‑80 mg) under ANDA 076532.