TESTODERM TTS

FDA-2015-P-4601 · 5 docket documents

Frier & Levitt, on behalf of licensed pharmacy and outsourcing facility clients, filed this citizen petition requesting that the FDA refrain from adding implantable testosterone pellets to the demonstrably difficult to compound list under sections 503A and 503B of the Federal Food, Drug, and Cosmeti

FDA-2014-P-0241 · 2 docket documents

Public Citizen petitioned the FDA pursuant to the Federal Food, Drug, and Cosmetic Act to add a black box warning about cardiovascular risks to all testosterone-containing drugs currently on the market, request manufacturers send "Dear Doctor" letters to physicians, update the FDA-approved Medicatio

FDA-2014-P-0258 · 3 docket documents

Public Citizen, a consumer advocacy organization, filed this citizen petition on February 25, 2014, pursuant to 21 U.S.C. § 352 and 21 C.F.R. §§ 10.30 and 201.56, requesting that the FDA immediately add a black box warning about increased cardiovascular risks to all testosterone-containing drugs cur

FDA-2013-P-0371 · 5 docket documents

Auxilium Pharmaceuticals, Inc. filed this citizen petition on March 26, 2013 under section 505(b)(2) regarding Upsher-Smith Laboratories' testosterone transdermal gel 1% application (No. 204399) citing Auxilium's Testim as the reference listed drug, requesting that FDA refrain from assigning an "A"

FDA-2012-P-0737 · 4 docket documents

Actient Pharmaceuticals LLC filed this citizen petition under 21 USC 355 and 21 CFR 10.30 on July 9, 2012, requesting that the FDA refrain from approving any abbreviated new drug application (ANDA) referencing Testopel Pellets (testosterone) for subcutaneous implantation without requiring sponsors t

FDA-2011-P-0610 · 8 docket documents

Abbott Laboratories, represented by Mayer Brown LLP, filed this citizen petition on August 18, 2011, requesting that the FDA refrain from granting a therapeutic equivalence rating to any new drug submitted under section 505(b)(2) that references AndroGel (testosterone gel) until FDA conducts a notic

FDA-2010-P-0613 · 4 docket documents

Watson Laboratories, Inc. filed this citizen petition on November 23, 2010, requesting that the FDA not approve any Abbreviated New Drug Application for a generic version of ANDRODERM (testosterone transdermal system) unless the applicant demonstrates bioequivalence using additional pharmacokinetic

FDA-2010-P-0196 · 6 docket documents

Hogan & Hartson, LLP, on behalf of Abbott Laboratories, submitted this citizen petition under 21 U.S.C. §§ 355(b) and 355(q) requesting that FDA require any applicant seeking to reference Abbott's AndroGel (testosterone gel) with different penetration enhancers than the reference product to conduct