CYTOXAN

FDA-2023-P-2655

Epic Pharma LLC filed this petition pursuant to Section 505(j)(2)(C) of the FD&C Act and 21 CFR 314.161 requesting that the FDA Commissioner determine whether CYTOXAN (cyclophosphamide for injection, USP) in the formulation of sterile dry powder without added excipient at 500 mg, 1 gm, and 2 gm vial

FDA-2020-P-1344

Lachman Consultant Services, Inc. filed this citizen petition under 21 CFR 314.161 on behalf of a client requesting that the FDA Commissioner determine that all discontinued formulations and strengths of Cytoxan (cyclophosphamide) Injection approved under NDA 012142, including the dry powder excipie

FDA-1995-P-0359

Law offices Kleinfeld, Kaplan and Becker filed this petition on behalf of an unnamed company seeking ANDA approval for oral dosage forms of cyclophosphamide and etoposide under 21 U.S.C. §355(j). The petitioner requests that the FDA issue guidance specifying that human bioavailability or bioequivale

FDA-2013-P-0241

Foley & Lardner LLP filed this citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that FDA determine that Cytoxan (cyclophosphamide) for Injection lyophilized formulation, originally approved under NDA 12-142, was not withdrawn from sale for reasons re

FDA-2001-P-0154

ASTA Medica, Inc. filed this citizen petition on July 26, 2001, requesting that the FDA determine that Bristol-Myers Squibb's non-lyophilized Cytoxan (cyclophosphamide for injection, USP) 2 g vials were voluntarily withdrawn from marketing for reasons other than safety or efficacy pursuant to 21 CFR

FDA-2012-P-1160

Steven A. Zecola filed this citizen petition on November 15, 2012, requesting that the FDA withdraw approval of ACT chemotherapy (Adriamycin, Cytoxan, and Taxol) as adjuvant therapy for BRCA1-related breast cancer patients, arguing that clinical trial data supporting its use in triple-negative breas