Regulatory Updates

The FDA has approved ANDA078594 for a 1% ciclopirox prescription shampoo, a topical treatment manufactured by Padagis US.

FDA records indicate the FLUTEX topical ointment (0.1% Triamcinolone Acetoinide) by IVAX PHARMS is discontinued, with original ANDA approval in 1988 and a labeling supplement in 1992.

Solubiomix received FDA approval for ANDA 076329 for a prescription topical lotion containing 0.1% amcinonide.

Epic Pharma LLC filed ANDA078975 for a discontinued topical ciclopirox 8% solution; FDA records show the original submission was approved on 2010-02-17.

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.

FDA lists ANDA076603 for Betamethasone dipropionate 0.05% cream by Chartwell Molecular; the product is marked discontinued.

FDA issued an approval letter on Sep 25, 2007 for Teva Pharms' ANDA 078079 covering a discontinued ciclopirox 8% topical solution.

The FDA record for NDA 008048 shows XYLOCAINE ointment, a discontinued 5% lidocaine topical, received multiple approved manufacturing and labeling submissions from 1984 to 1996.

FDA records show a series of approved labeling and manufacturing supplemental applications for the discontinued LINDANE 1% topical lotion under ANDA 087313.

The FDA approved Diprosone lotion, a topical betamethasone dipropionate product (0.05% base) under NDA 017781. It is listed as discontinued but not withdrawn for safety reasons.

The FDA has approved ANDA077168 for a prescription topical ointment containing 0.005% fluticasone propionate, manufactured by Cosette Pharmaceuticals.