規制動向

FDA、EMA、TGA および世界の規制動向

#Topical Ointment ×

2026年9月28日•1分で読めます

FDA Discontinues Hydrocortisone 0.5% Ointment (ANDA084969)

The FDA has listed the hydrocortisone 0.5% topical ointment (product 003) from Perrigo New York as discontinued under application ANDA084969.

2026年9月24日•1分で読めます

FDA Approves ANDA217117 for LIDOCAINE Topical Ointment

The FDA has approved Aurobindo Pharma's LIDOCAINE 5% topical ointment (ANDA217117) for prescription use, with a standard review completed on June 18, 2024.

2026年9月19日•1分で読めます

FDA Approves Mometasone Furoate Topical Ointment (ANDA076481)

FDA granted approval for ANDA076481, a prescription 0.1% mometasone furoate topical ointment manufactured by Encube Ethicals, Inc.

2026年9月15日•1分で読めます

Glenmark Pharm's Mometasone Furoate Ointment (ANDA078571) Receives Multiple Labeling Approvals

The FDA approved the original ANDA for Glenmark's Mometasone Furoate topical ointment on May 28, 2008, and later granted labeling supplements in 2015 and 2024; the product is now discontinued.

2026年8月24日•1分で読めます

FDA Approves Padagis Israel’s Desoximetasone 0.25% Topical Ointment (ANDA077770)

The FDA granted approval (ANDA077770) for Padagis Israel’s prescription topical ointment containing 0.25% desoximetasone.