Actualités réglementaires

The FDA lists HEXASCRUB, a 3% hexachlorophene topical sponge, under application NDA018363 with a discontinued marketing status. Sponsor: PROF DSPLS.

The FDA issued an approval letter for Mylan Pharm Inc.’s topical ciclopirox 8% solution (ANDA 078567), though the product is listed as discontinued.

The FDA has approved a prescription topical lotion containing 12% ammonium lactate, submitted under ANDA 076216 by Sun Pharma Canada.

The FDA’s ANDA088048 for a fluocinolone acetonide 0.01% topical solution submitted by Allied is listed as discontinued.

Alvogen’s discontinued topical gel CICLOPIROX (0.77%) received FDA labeling submissions in 2013, with earlier filings dating back to 1997.

The FDA has approved ANDA087315 submitted by Alpharma US Pharms for a 1% hydrocortisone topical lotion, currently listed as discontinued.

The FDA has approved ANDA 078338 for a prescription 1% clotrimazole topical cream marketed by Fougera Pharmas.

The FDA approved ANDA087081 for a 0.2% nitrofurazone topical solution submitted by Wendt; the product is listed as discontinued.

FDA approved application ANDA078541 for a 0.1% mometasone furoate topical cream by Glenmark Pharmaceuticals. Original approval in 2008 with later labeling updates; product now discontinued.

The FDA granted approval (ANDA080482) to C & M Pharma for two topical hydrocortisone cream products, both now listed as discontinued.

The FDA record shows UTICORT lotion, a 0.025% betamethasone benzoate topical product by Parke‑Davis, is listed as discontinued.

The FDA has listed the topical Triamcinolone Acetoinide 0.1% cream, sponsored by Morton Grove, as discontinued under ANDA 088095.