SuperGen mitomycin C oncologic reformulation is in final labeling discussions with FDA, firm says.
Executive Summary
SUPERGEN MITOMYCIN C GENERIC ONCOLOGY DRUG IN FINAL LABELING discussions with FDA, and the company expects approval for the reformulation of mitomycin C later this spring or summer, Chief Financial Officer David Fineman announced at the Dillon Read conference May 7. The company filed the ANDA for mitomycin C in March 1995. The drug is used mostly for gastric and pancreatic cancers. During 1996, SuperGen expects filings to go to FDA for reformulated versions of etoposide, vincristine and cisplatin, Fineman noted.