Durata Therapeutics products
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Dalvance®
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Generic Name: dalbavancin
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Indication: intravenous treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by Gram-positive pathogens, including MRSA.
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Key Feature: Long-acting lipoglycopeptide antibiotic given as two IV doses one week apart.
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Development Notes:
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First approved in the U.S. in May 2014.
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High-impact designation as the first Qualified Infectious Disease Product (QIDP) under FDA’s GAIN Act.
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Late-stage trials explored single-dose regimens and additional indications like osteomyelitis and community-acquired pneumonia.
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