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news.Optimer Pharmaceuticals has filed a new drug submission (NDS) with the Therapeutic Products Directorate of Health Canada (Health Canada) for Dificid (fidaxomicin) tablets to treat Clostridium difficile infection (CDI).
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Health Canada has granted Optimer priority review of the Dificid NDS, reducing the time to a potential regulatory approval in Canada.
The NDS is based on the results of two Phase 3 clinical studies of Dificid in patients with CDI.
The multi-center, randomized, double-blind trials enrolled a total of 1,164 adult subjects who demonstrated the efficacy of Dificid.
Optimer Pharmaceuticals is focused on discovering, developing and commercializing innovative hospital specialty products.