Trials & Filings

Durata Submits MAA for Dalbavancin

EU application follows priority review from FDA

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Durata Therapeutics has submitted an MAA to the EMA for dalbavancin, for the treatment of patients with complicated skin and soft tissue infections (cSSTI) caused by susceptible Gram-positive microorganisms, including Staphylococcus aureus (including methicillin-resistant strains) and Streptococcus pyogenes, as well as certain other streptococcal species. Following the standard EMA review cycle timing, the company anticipates a decision in 1H15. If approved, dalbavancin will be the first drug f...

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