規制動向

FDA、EMA、TGA および世界の規制動向

#GLIMEPIRIDE ×

2026年9月27日•1分で読めます

FDA Approves ANDA077370 for Generic Glimepiride Tablets

The FDA has approved application ANDA077370 for generic glimepiride tablets (1‑8 mg) manufactured by Solco Healthcare U.S., LLC and sponsored by Prinston Inc.

2026年9月5日•1分で読めます

FDA Approves ANDA 076802 for Glimepiride Tablets (Discontinued)

FDA approved ANDA 076802 for oral glimepiride tablets in 1 mg, 2 mg and 4 mg strengths; all listed as discontinued after multiple labeling supplements.

2026年8月30日•1分で読めます

Mylan's GLIMEPIRIDE ANDA077486 Receives FDA Approval

The FDA approved Mylan's ANDA077486 for GLIMEPIRIDE tablets (1mg, 2mg, 4mg), though all listed products are marked as discontinued.