Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves RETIN-A (Tretinoin) Topical Gel – NDA 017579
The FDA has approved NDA017579 for RETIN-A, a prescription 0.025% tretinoin topical gel marketed by Bausch Health US and Mylan Pharmaceuticals.
Regulatory Updates
Sep 5, 2026•1 min read
Isotretinoin linked to joint pain in 50‑year‑old woman with seborrheic dermatitis
A Korean pharmacovigilance report describes a 50‑year‑old female patient who experienced joint pain after 11 months of isotretinoin therapy for seborrheic dermatitis.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA078594 for Topical Ciclopirox Shampoo
The FDA has approved ANDA078594 for a 1% ciclopirox prescription shampoo, a topical treatment manufactured by Padagis US.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Grants ANDA Approval for Amcinonide Topical Lotion (ANDA076329)
Solubiomix received FDA approval for ANDA 076329 for a prescription topical lotion containing 0.1% amcinonide.
Regulatory Updates
Aug 30, 2026•1 min read
Fougéra Pharms Receives FDA Approval for Alclometasone Dipropionate Topical Ointment (ANDA 076884)
The FDA approved an ANDA for alclometasone dipropionate 0.05% topical ointment submitted by Fougéra Pharms. Original approval was granted in July 2005 with a labeling supplement in August 2015.
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Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA076603 for Betamethasone Dipropionate Topical Cream
FDA lists ANDA076603 for Betamethasone dipropionate 0.05% cream by Chartwell Molecular; the product is marked discontinued.
Regulatory Updates
Aug 25, 2026•1 min read
MHRA Warns of Risks with Prolonged Use of High-Potency Topical Steroids
MHRA notes topical steroids are effective but carry serious risks, especially with long‑term high‑potency use, and will update labelling soon.
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Regulatory Updates
Aug 24, 2026•1 min read
CHM Endorses Updated Isotretinoin Prescribing Guidance, Seeks Service Feedback
The Commission on Human Medicines has approved new prescribing guidance for isotretinoin and is gathering data from dermatology services for future updates.