FDA Approves Dalbavancin to Treat Adult Skin Infections

4 years ago
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us food and drug administration

 

The U.S. Food and Drug Administration approved a new antibacterial drug Dalvance (dalbavancin) for use in the treatment of adult skin infections.

Dalbavancin is intended to treat Acute Bacterial Skin and Skin Structure Infections (ABSSSI). ABSSSI is caused by certain susceptible bacteria like Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) and Streptococcus pyogenes. The treatment is administered intravenously.

As FDA report states “Dalvance is the first drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, Dalvance was granted QIDP designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections.” As the drug is made part of QIDP designation it given a priority review, which provides an expedited review of the drug’s application. It also qualifies drug for 5 years exclusive marketing.

Dalbavancin is a novel 2nd generation lipoglycopeptide antibiotic and it belongs to the same class as that of Vancomycin which is most widely used the drug for treatment of MRSA (Methicillin Resistant Staphylococcus Aureus) infection. It has shown in-vitro effectivity against gram-positive pathogens like MRSA and MRSE (Methicillin Resistant Staphylococcus Epidermidis).

Dalbavancin is marketed by Chicago-based Durata Therapeutics, a company which acquired the rights to this drug.

ABSSSI is an acute bacterial infection of the skin and associated tissues. It includes complicated and uncomplicated types and requires antibiotic treatment.

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