FDA approves new DALVANCE label

The FDA has approved the new label for DALVANCE | morguefile.com

The Food and Drug Administration (FDA) last week approved Allegran’s supplemental new drug application (sNDA) that will allow the company to update its DALVANCE label.

DALVANCE was designed to treat acute bacterial skin and skin structure infections (ABSSSI) and is the only 30-minute single-dose treatment on the market. It is also the first of its kind. The updated label will contain instructions for a single dose of the product administered as a 30-minute intravenous (IV) injection.

The rate at which people were hospitalized for ABSSSI rose 17.3 percent between the years 2005 and 2011 with more than 750,000 admissions in 2011. DALVANCE could be used to lower the pressure being put on hospitals to decrease hospitalizations and readmissions. The option for the single-dose usage of DALVANCE could also help patients avoid being hospitalized in the first place.

Being that DALVANCE is the only medicine on the market to treat ABSSSI and can now provide a full course of treatment in just 30 minutes, it will give a variety of treatment options to health-care providers. Allegran will continue its advancement of DALVANCE in hopes of helping provide positive outcomes for patients suffering from ABSSSI.

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Allergan, Inc. 400 Interpace Pkwy Parsippany, NJ 07054-1116