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Nov 12, 2012
 |  BC Week In Review  |  Clinical News  |  Regulatory

Dalbavancin regulatory update

FDA granted Qualified Infectious Disease Product (QIDP) designation to Durata's dalbavancin to treat acute bacterial skin and skin structure infections (ABSSSI). Dalbavancin is now eligible for an additional 5 years of market exclusivity and will automatically receive Priority Review and Fast Track designation under the Generating Antibiotic Incentives Now (GAIN) program. The second-generation, once-weekly glycopeptide antibiotic is in Phase III testing for ABSSSI. The company plans to submit an...

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