ONDANSETRON

FDA-2019-P-5151 · 72 docket documents

GlaxoSmithKline LLC filed this citizen petition pursuant to 21 C.F.R. § 10.30 requesting that the FDA Commissioner review four categories of information concerning Zofran (ondansetron) use in pregnancy and either refrain from altering the drug's pregnancy-related labeling or, if alteration is deemed

FDA-2014-P-1752 · 4 docket documents

Dara BioSciences filed a citizen petition with the FDA requesting that the agency deny or withdraw approval of orally disintegrating tablet formulations of ondansetron, or alternatively, that the FDA condition approval of these products on comparative bioavailability studies demonstrating superiorit

FDA-2013-P-0048 · 5 docket documents

James P. Reichmann filed this citizen petition on January 4, 2012, requesting the FDA reclassify ondansetron (Zofran) from pregnancy risk category B to category C, D, or X pursuant to 21 U.S.C. Section 355(e)(3), and to notify obstetrician-gynecologists that insufficient scientifically acceptable ev

FDA-2011-P-0166 · 6 docket documents

Lachman Consultant Services, Inc. filed this petition on March 16, 2011, pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA declare Ondansetron Effervescent Tablets, 8 mg, suitable for consideration in an ANDA, with Zofran ODT (ondansetron orally di

FDA-2007-P-0477 · 7 docket documents

Lachman Consultant Services, Inc. filed this petition on behalf of MonoSoIRx, LLC pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Ondansetron Orally Dissolving Strips in 4 mg, 8 mg, 16 mg, and 24 mg strengths suitable for consideration in