法规动态

FDA、EMA、TGA 及全球法规动态

#baclofen ×

2026年9月28日•1 分钟阅读

FDA Approves Manufacturing Supplements for LIORESAL (baclofen) Tablets

The FDA has approved a series of priority manufacturing (CMC) supplement submissions for the discontinued LIORESAL baclofen tablets (10 mg and 20 mg).

2026年9月11日•1 分钟阅读

FDA Approves ANDA209102 for Generic Baclofen Tablets

The FDA approved ANDA209102 for generic baclofen oral tablets in 5‑20 mg strengths, manufactured by TruPharma, Advagen Pharma and SOLA Pharmaceuticals.