Federal Register Notice: FDA has determined that although Bristol-Myers Squibb has discontinued marketing Cytoxan, 2 g vial (cyclophosphamide for injection), the formulation was not withdrawn from sale for reasons of safety and effectiveness. Sponsors of any unapproved ANDAs seeking to use Cytoxan as the reference-listed drug, should reference Bristol-Myers Squibb’s approved new formulation, cyclophosphamide lyophilized. To view this notice, click here.
