Mylan Launches Generic Mutamycin Injection, Adds To Growing Oncology Portfolio

Mylan launched the oncology drug Mitomycin for Injection USP, 5 mg/vial, 20 mg/vial and 40 mg/vial Single Dose Vials, a generic version of the reference listed drug, Bristol Myers Squibb’s Mutamycin in the U.S. market to be used in combination with other cancer medicines in the treatment of stomach and pancreatic cancers.

Mylan 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 FDA.

Mylan’s injectables portfolio is one of the largest and most diversified in the industry, with approximately 80 injectable products in the U.S. across several therapeutic areas. Mylan is also one of the largest suppliers of cancer medicines by volume in the U.S.

U.S. sales for Mitomycin for Injection USP, 5 mg/vial, 20 mg/vial and 40 mg/vial Single Dose Vials were approximately $59 million for the 12 months ending Jan. 31, 2018, according to IQVIA.

According to its indication, Mitomycin Injection is not recommended as a single-agent, primary therapy. It has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. Mitomycin is not recommended to replace appropriate surgery and/or radiotherapy.

(Source: Mylan N.V.)