Trials & Filings

Merck’s Noxafil IV Gets Priority Review

IV antifungal to treat Aspergillus, Candida infections

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Merck has received Priority Review status from the FDA for its NDA of an IV solution formulation of antifungal agent, Noxafil. The company has filed an MAA for Noxafil IV solution with the EMA and plans to seek regulatory approval for the IV formulation in other countries around the world. Priority review designation is assigned to applications for drugs that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious ...

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