Optimer drug gets 6-month FDA review

Optimer drug gets 6-month FDA review

April 14th, 2011 // 11:33 am @

Jan. 24, 2011: SAN DIEGO (AP) — Optimer Pharmaceuticals Inc. said Monday the Food and Drug Administration will give the company’s potential bacterial infection drug Fidaxomicin priority review.

Under priority review, the FDA aims to review a potential drug within 6 months instead of the usual 10-month period. Optimer expects an FDA decision by May 30.

Fidaxomicin is aimed at treating Clostridium difficile infection, which causes diarrhea and potentially life-threatening inflammation of the colon.

 


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