LYPHOMED's READY-TO-USE LYPHOCIN (VANCOMYCIN HCI) INJECTION IS "APPROVABLE"

Executive Summary

LyphoMed's Lyphocin (vancomycin HCI) is approvable. The vancomycin eq 50 mg base/ml injectable product reached the approvable stage on July 29. Although vancomycin is available generically, LyphoMed had to go the NDA route because of the formulation of its liquid product. Lyphocin is a ready-to-use formulation, whereas the reference product, Lilly's Vaconcin, is supplied in vials containing lyophilized vancomycin equivalent to 500 mg or 1 g vancomycin base. Lyphocin is being manufactured at LyphoMed's Melrose Park facility, the company said. As a result of compliance problems, both the company's Melrose Park plant and Orlando facility have been under close scrutiny by FDA. The generic drug company has taken the NDA route with a number of its products. LyphoMed filed a full NDA and conducted clinicals for its injectable pentamidine product Pentam 300, which is now marketed as a treatment for AIDS-related pneumocystis carinii pneumonia (PCP). LyphoMed is currently developing an aerosol form of pentamidine for both treatment and prevention of PCP. As of the end of July, FDA has approved four new chemical entities, including Ciba-Geigy's nonsteroidal anti-inflammatory agent Valtaren. In addition, Smith Kline's Herbert labs received approval for the antifungal Naftin in February, Berlex received approval for Magnevist, a magnetic resonance imaging contract medium, in June, and Lilly received approval for Axid, an H[2]-antagonist, in April. FDA Commissioner Young had predicted that the agency would approved 11 new chemical entities by March 31 ("The Pink Sheet" Jan. 25, 1988, "In Brief").