ACCUTANE

FDA-2018-P-4088

Data Based Medicine Americas Ltd., represented by David Healy and colleagues, filed this citizen petition on October 26, 2018, requesting that the FDA immediately revise all isotretinoin product labels (both branded and generic formulations) to add warnings, precautions, highlights of prescribing in

FDA-2014-P-1282

Morgan Lewis & Bockius LLP filed an amendment to a suitability petition (Docket No. FDA-2014-P-1282) originally submitted July 17, 2014, seeking permission to file an ANDA for Isotretinoin Capsules in 15 mg, 25 mg, and 35 mg strengths. The petitioner provided complete proposed product labeling for t

FDA-2014-P-1282

Morgan Lewis & Bockius LLP filed this suitability petition on behalf of an unnamed client under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA declare three new strengths of Isotretinoin Capsules USP (15 mg, 25 mg, and 35 mg) suitable for submission and FDA

FDA-2012-P-0906

Lachman Consultant Services, Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug and Cosmetic Act on August 15, 2012, requesting that the FDA designate Absorica (isotretinoin capsules), subject of NDA 021951 held by Cipher Pharmaceuticals, as a second reference listed dru

FDA-2010-P-0171

Sun Pharmaceutical Industries, Inc., as the US Agent for Sun Pharma Global FZE, filed this citizen petition on March 22, 2010, requesting that the FDA determine the discontinued formulation of ACCUTANE (Isotretinoin capsules) in 10 mg, 20 mg, and 40 mg strengths was not withdrawn for safety or effic