規制動向

FDA、EMA、TGA および世界の規制動向

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2026年9月12日•1分で読めます

FDA Approves NDA020675 for URSO 250 and URSO FORTE (Ursodiol) Tablets

The FDA granted approval for NDA020675 covering URSO 250 (250 mg) and URSO FORTE (500 mg) ursodiol tablets from Allergan, though both products are now listed as discontinued.

2026年9月5日•1分で読めます

FDA Discontinues FLUONID Topical Ointment (ANDA 087157)

The FDA lists the FLUONID ointment (0.025% fluocinonide) under ANDA 087157 as discontinued, sponsored by Allergan Herbert.