Determination That CYTOXAN (Cyclophosphamide) for Injection (Sterile Dry Powder Excipient-Free Formulation), 500 Milligrams/Vial, 1 Gram/Vial, and 2 Grams/Vial, and CYTOXAN (Cyclophosphamide) for Injection (Sterile Dry Powder With Sodium Chloride Formulation), 500 Milligrams/Vial, 1 Gram/Vial, and 2 Grams/Vial, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA or the Agency) has determined that the sterile dry powder excipient-free formulation of CYTOXAN (cyclophosphamide) for Injection, 500 milligrams (mg)/vial, 1 gram (g)/vial, and 2 g/vial, and the sterile dry powder with sodium chloride formulation of CYTOXAN (cyclophosphamide) for Injection, 500 mg/vial, 1 g/vial, and 2 g/vial, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to the sterile dry powder excipient- free formulation or the sterile dry powder with sodium chloride formulation of these drug products, and it will allow FDA to continue to approve ANDAs that refer to these formulations of CYTOXAN as long as they meet relevant legal and regulatory requirements.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.