US FDA approves Optimer's Dificid for C. difficile infection

Following a positive advisory panel recommendation last month, the US Food and Drug Administration has approved Optimer Pharmaceuticals’ (Nasdaq: OPTR) Dificid (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea (CDAD), the first such drug to be cleared by the agency in around 25 years (The Pharma Letter April 7).

C. difficile is a bacterium that can cause diarrhea and lead to colitis, other serious intestinal conditions, and death in severe cases. C. difficile bacteria are found in the stool of an infected person, and others can become infected if they touch items or surfaces contaminated with the bacteria or spores and then touch their mouths.

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