CLIMARA

FDA-1998-P-0666 · 20 docket documents

Berlex Laboratories, Inc. and 3M Pharmaceuticals filed this citizen petition under section 505(j) requesting that the FDA establish approval standards for generic transdermal estradiol patches before approving any abbreviated new drug application for such products. The petitioners request that the A

FDA-2004-P-0295 · 4 docket documents

Dr. Ekkehard Kemmann of the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School filed a petition requesting that the FDA remove the Category X pregnancy labeling categorization for estradiol, arguing that the categorization is inappropriate given that estradiol occu

FDA-2010-P-0403 · 3 docket documents

Novo Nordisk Inc. filed this citizen petition on July 26, 2010, requesting that the FDA require any ANDA applicant for generic Vagifem (estradiol vaginal tablets) in 10 and 25 microgram strengths to include labeling recommending the 10 microgram dosage and to refrain from approving any generic ANDAs

FDA-2006-P-0348 · 5 docket documents

Duramed Research, Inc., a subsidiary of Barr Pharmaceuticals, filed this citizen petition on July 14, 2006, requesting that the FDA require all Abbreviated New Drug Applications referencing Duramed's NDA No. 21-544 for Seasonale (0.03 mg ethinyl estradiol/0.15 mg levonorgestrel) to conduct bioequiva

FDA-2009-P-0089 · 4 docket documents

Novo Nordisk Inc. filed this citizen petition on February 18, 2009, requesting that the FDA refrain from approving any ANDA for a generic version of Vagifem (estradiol vaginal tablets) 25 micrograms unless the applicant provides data from adequate and well-controlled multiple endpoint clinical trial

FDA-2005-P-0006 · 5 docket documents

Warner Chilcott Inc. filed this citizen petition on January 21, 2005, requesting that the FDA stay final approval of any abbreviated new drug applications (ANDAs) for estradiol vaginal cream 0.01% products unless the applications contain data demonstrating bioequivalence and therapeutic equivalence

FDA-2008-P-0587 · 3 docket documents

Warner Chilcott Company, Inc. submitted this citizen petition under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require any ANDA relying on Loestrin 24 Fe Tablets (norethindrone acetate 1 mg and ethinyl estradiol 20 mcg with ferrous fumarate, NDA 21-871) as the re

FDA-2008-P-0296 · 20 docket documents

Public Citizen filed this citizen petition pursuant to 21 U.S.C. Section 355(e)(3) and 21 C.F.R. 10.30, requesting that the FDA ban the transdermal contraceptive patch Ortho-Evra (ethinyl estradiol/norelgestromin, manufactured by Johnson & Johnson) with market removal within six months, citing evide

FDA-2007-P-0171 · 5 docket documents

Warner Chilcott Inc. filed this petition requesting that the Food and Drug Administration refrain from approving abbreviated new drug applications for 0.4 mg Norethindrone and 35 µg Ethinyl Estradiol chewable tablets unless applicants demonstrate bioequivalence to both Ovcon-35 Oral Tablets and Femc