FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs / Submissions and Approvals

EU Review Panel OKs New Formulation of Merck’s Antibiotic Noxafil

March 3, 2014
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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) is recommending a new, investigational tablet version of Merck’s antibiotic Noxafil.

The European Commission will have the final say on whether the new Noxafil (posaconazole) tablet is approved. Its approval would extend the product’s marketing power in the face of encroaching generic competitors. The EMA recently published guidance detailing how bioequivalence studies will be conducted for 16 active substances, including for posaconazole.

A delayed-release formulation of the Merck tablet is approved in the U.S. to treat invasive aspergillus and candida infections in patients 13 years of age and older at high risk of developing those infections due to being severely immunocompromised. — Johnathan Rickman

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