Posted by Michael Wonder on 23 Oct 2015
Spectrum Pharmaceuticals receives complete response letter from U.S. Food and Drug Administration for Evomela (melphalan) for injection
23 October 2015 - A complete response letter is a communication from the FDA that informs companies that an application cannot be approved in its present form. In the letter, the FDA did not identify any clinical deficiency in Spectrum's NDA package.
For more details, go to: http://investor.sppirx.com/releases.cfmhttp://investor.sppirx.com/releases.cfm
