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Drugs for Rare and Infectious Diseases
FDA Drug Approvals for Rare Diseases and Infectious Diseases Generating Antibiotics Incentives Now Act GAIN Act (S.1734)
The GAIN Act provides incentives to help bring new antibiotics and other antimicrobials to market.
A drug with particular promise can be designated as a Qualified Infectious Disease Product (QIDP) by authority of the GAIN Act.
In 2014, FDA/CDER approved four new antibiotics…
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Durata Therapeutics Announces the U.S. Launch of DALVANCE(TM)
Durata Therapeutics Announces the U.S. Launch of DALVANCE(TM)
Last week, Durata Therapeutics, Inc. (Nasdaq:DRTX) announced that DALVANCE (dalbavancin) for injection is now available for use to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI). DALVANCE was approved by the U.S. Food and Drug Administration (FDA) on May 23, 2014 and was the first drug approved as a Qualified Infectious Disease Product (QIDP). Durata began…
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