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Long Time Coming

Durata Files Dalbavancin NDA; Approval Could Occur by May

By Randy Osborne
Staff Writer

Monday, September 30, 2013
The antibiotic dalbavancin’s long road to approval seems likely to end near the end of next May, now that Durata Therapeutics Inc. has submitted the new drug application (NDA) for the drug targeting acute bacterial skin and skin structure infections caused by gram-positive microorganisms, including the hospital scourge known as MRSA: methicillin-resistant Staphylococcus aureus.

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