SUBSYS

FDA-2010-P-0599 · 3 docket documents

Law firm Kramer & Amado, P.C. filed this citizen petition on behalf of a client on November 17, 2010, requesting that the FDA determine that Cephalon, Inc.'s discontinuation of Fentora (fentanyl buccal tablet) 0.3 mg strength was not for safety or effectiveness reasons, thereby allowing generic alte

FDA-2006-P-0329 · 8 docket documents

Mylan Technologies Inc. filed this petition under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require all applicants for fentanyl transdermal systems, including generic versions like Mylan's bioequivalent product, to conduct studies supporting the safe use of an o

FDA-2010-P-0413 · 6 docket documents

The law firm Olsson Frank Weeda Terman Bode Matz PC filed this citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine a new strength of Fentanyl Citrate Injection, USP at 50 mcg (50 mcg/1mL) is suitable for submission as an abbreviat

FDA-2010-P-0396 · 4 docket documents

Cephalon, Inc. filed this citizen petition under 21 U.S.C. § 355 and 21 C.F.R. § 10.30 requesting that the FDA revise its draft bioequivalence guidance for fentanyl citrate buccal tablets and require sponsors of abbreviated new drug applications referencing FENTORA (fentanyl buccal tablet) to demons

FDA-2010-P-0383 · 17 docket documents

Cephalon, Inc., filed this citizen petition on July 13, 2010, requesting that FDA withdraw its acceptance for filing, reject, and ultimately require Watson Pharmaceuticals to resubmit as a new drug application under Section 505(b)(2) rather than proceed with ANDA No. 79-075 for fentanyl buccal table

FDA-2004-P-0274 · 4 docket documents

Alza Corporation filed this citizen petition requesting that the FDA classify transdermal fentanyl matrix systems differently from reservoir systems (like Duragesic) and not rate them as AB-equivalent, citing greater abuse potential since matrix products can be cut into discrete units permitting eas

FDA-2007-P-0062 · 7 docket documents

Lachman Consultant Services, Inc. filed this petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Oral Transmucosal Fentanyl Citrate in 1000 mcg and 1400 mcg strengths suitable for submission as an ANDA, with Actiq (oral

FDA-2006-P-0016 · 10 docket documents

Mylan Laboratories Inc. filed this citizen petition on July 21, 2006, requesting that the FDA determine whether a Risk Management Program is necessary for transdermal fentanyl drug products and, if so, that the FDA develop and adopt a single, unified Risk Management Program for all transdermal fenta