Actualités réglementaires

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.

The FDA approved ANDA078598, submitted by J Molner, for a 0.3% ciprofloxacin hydrochloride ophthalmic solution. The product is listed as discontinued.

The FDA has approved Fougera Pharms' CALCIPOTRIENE 0.005% topical solution under ANDA 078305, a new prescription product.

FDA granted approval for Cipla's ANDA078003 generic esomeprazole magnesium, covering two discontinued oral capsule products.

FDA has approved Teva Pharm’s methylphenidate hydrochloride extended‑release capsules in 10 mg, 20 mg and 30 mg strengths under ANDA 077707.

Cipla's ANDA 077411 for a prescription tablet combining lamivudine 150 mg and zidovudine 300 mg has been approved by the FDA.

FDA has approved multiple labeling supplements for the discontinued VALPROIC ACID oral syrup (ANDA 077105). Original approval dates to 2005.

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.

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.

Critics argue the draft amendment imposes unnecessary duties on employers and undermines pharmacies' professional market position.

The FDA approved ANDA 076815 submitted by Parenta Pharms for a 5 mg/mL injectable diazepam product, currently listed as discontinued.

The FDA granted tentative approval to Teva Pharm’s generic simvastatin tablets (5‑80 mg) under ANDA 076532.