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Published On: Mon, Nov 5th, 2012

Antibiotic candidate, dalbavancin, designated as a Qualified Infectious Disease Product by the FDA

The intravenous antibiotic product candidate, dalbavancin,  has been designated as a Qualified Infectious Disease Product (QIDP) by the Food and Drug Administration (FDA), making it eligible for fast-track status, according to Durata Therapeutics press release Nov. 5.

Image/CDC

Dalbavancin is Durata’s lead product candidate, currently under investigation for the treatment of ABSSSI caused by susceptible Gram-positive bacteria, including MRSA (methicillin resistant Staphylococcus aureus).

The drug candidate is under investigation for once-weekly dosing, which we believe may facilitate the treatment of patients with ABSSSI in both the in-patient and out-patient settings, potentially reducing the length of a patient’s hospital stay or avoiding hospital admission altogether, with an impact on the overall cost of care for these patients.

“By expediting the FDA review process, the QIDP designation will help us bring dalbavancin to patients who face serious skin infections more quickly. QIDP status also complements the intellectual property protections provided by our underlying patents. If the FDA approves dalbavancin for the treatment of ABSSSI, we would receive 10 years of exclusivity in the U.S., the same duration provided by regulatory agencies in Europe,” said Durata Therapeutics CEO Paul R. Edick.

Durata is currently enrolling patients in two global Phase 3 clinical trials with its lead product candidate, dalbavancin, under investigation for the treatment of patients with acute bacterial skin and skin structure infections, or abSSSI, caused by susceptible Gram-positive bacteria.

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About the Author

- Writer, Co-Founder and Executive Editor of The Global Dispatch. Robert has been covering news in the areas of health, world news and politics for a variety of online news sources. He is also the Editor-in-Chief of the website, Outbreak News Today and hosts the podcast, Outbreak News Interviews on iTunes, Stitcher and Spotify Robert is politically Independent and a born again Christian Follow @bactiman63

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