Optimer Pharmaceuticals, Inc. (OPTR) said Tuesday that the U.S. Food and Drug Administration's Anti-Infective Drugs Advisory Committee has recommended approval of the company's investigational antibiotic Dificid for the treatment of patients with Clostridium difficile infection, a bacterial infection in the lining of the gut that can cause severe diarrhea, colitis and in some cases death.
In a unanimous 13-0 decision, the Committee found that the clinical evidence submitted by Optimer showed the safety and effectiveness of Dificid for the treatment of Clostridium difficile infection.
Optimer submitted its New Drug Application for Dificid on November 30, 2010. The FDA accepted the NDA filing and granted a six-month Priority Review in January, assigning a Prescription Drug User Fee Act goal date of May 30.
The FDA is not bound by the committee's advice but takes it into consideration while approving a drug.
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