AdventRx's application for Exelbine accepted by FDA
SAN DIEGO — The Food and Drug Administration has accepted the approval application for a chemotherapy drug to treat lung cancer from AdventRx Pharmaceuticals, the drug maker said Thursday.
The FDA accepted AdventRx’s application for Exelbine (vinorelbine). The drug is a branded generic, being formulated with the same active ingredient as Navelbine, originally marketed by French drug maker Pierre Fabre and now available as a generic from seven companies.
The company described itself as developing existing cancer drugs to improve their performance by addressing limitations associated with their safety and use. “We are pleased to have reached this important milestone and look forward to working with the FDA on moving Exelbine toward approval in 2011,” AdventRx CEO Brian Culley said.