Prexige not approvable

Novartis (NVS; SWX:NOVN) received a not approvable letter from FDA for an NDA for Prexige lumiracoxib to treat osteoarthritic pain. An NVS spokesperson declined to comment on the reasons FDA provided for its decision. NVS said FDA told the company that the agency "remained open to exploring the use of this medicine in patients where Prexige would provide an acceptable benefit-to-risk balance." NVS said this group could include patients with a higher incidence of gastrointestinal complications. ...