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23日•1分で読めます

FDA Approves Multiple Supplemental Applications for LIDOPEN (NDA 017549)

The FDA has granted approval for several supplemental submissions related to LIDOPEN, an injectable lidocaine product now discontinued.

2026年9月15日•1分で読めます

FDA Approves Multiple Labeling Supplements for MirtaZAPINE (ANDA 076901)

FDA's ANDA 076901 for MirtaZAPINE includes three discontinued oral tablet strengths and a series of approved labeling supplements dating from 2005 to 2025.

2026年9月10日•1分で読めます

FDA NDA 007883: Antabuse (disulfiram) supplemental manufacturing and labeling submissions

The FDA NDA 007883 for Antabuse lists two discontinued tablet strengths and a series of priority supplemental submissions for manufacturing and labeling, all approved.

2026年9月5日•1分で読めます

Quinapril Hydrochloride and Hydrochlorothiazide Tablets – FDA Labeling Approvals (ANDA 077093)

FDA records show labeling approvals for discontinued quinapril/hydrochlorothiazide tablets across multiple supplemental applications from 2011 to 2022.

2026年8月30日•1分で読めます

FDA Approves Supplemental ANDA 086178 for GLYCOPYRROLATE Tablet

FDA records approval of a supplemental manufacturing (CMC) submission for ANDA 086178, covering the oral GLYCOPYRROLATE 2 mg tablet by Watson Labs, now listed as discontinued.