Mylan N.V. has launched its generic version of BMSs oncology drug Mutamycin in USA, called Mitomycin, for which it noted is used in combination with other cancer medicines to treatment stomach and pancreatic cancers.
In an announcement on Tuesday, Mylan said it is offering Mitomycin for Injection USP, 5 mg/vial, 20 mg/vial and 40 mg/vial Single Dose Vials to its hospital and institutional customers after an Abbreviated New Drug Application (ANDA) for the product was approved by the U.S. Food and Drug Administration (FDA).
Mylan, one of the largest suppliers of cancer medicines by volume in the U.S., added to its injectables portfolio of about 80 injectable products in the U.S. across several therapeutic areas.
Mylan said that the U.S. sales were approximately $59 million for the 12 months ending Jan. 31, 2018, according to the provider of biopharmaceutical development and commercial outsourcing service, IQVIA.
According to its indication, Mitomycin Injection is not recommended as a single-agent, primary therapy, Mylan noted. Also, Mitomycin is not recommended to replace appropriate surgery and/or radiotherapy.