Durata Therapeutics confirms FDA approval of Dalvance, shares halted

Durata Therapeutics (DRTX) says the FDA has approved its Dalvance antibiotic for the treatment of patients with acute bacterial skin and skin structure infections.

Dalvance is the first drug with the qualified infectious disease product designation to receive FDA approval.

A March FDA advisory panel approval also had given a favorable review to a rival product from Cubist Pharmaceuticals (CBST); the FDA is set to rule on the CBST drug shortly.

DRTX shares halted.

Comments (1)
  • Dr Joseph Haluska
    , contributor
    Comments (499) | Send Message
    This makes history!
    One of the most important leaps forward for the FDA-and science:
    QIDP-the Qualified Infectious Disease Product designation, Dalvance being the first so-designated product. I have maintained that key to advancement of pharmaceutical technology-and lower prices-is to extend patent protection for the pharmaceutical industry's Intellectual Property. Under QIDP, in addition to giving priority review, the products also qualify for an ADDITIONAL 5 years of marketing exclusivity, TO BE ADDED TO certain exclusivity periods already provided by the Food, Drug and Cosmetic Act, as stated by the FDA.
    In my opinion, the QIDP program empowers the FDA more than ever before in history to maintain its ability to continue to ensure excellence in pharmaceutical science, while simultaneously fostering intellectual protection and nurturing advancement into the future. Furthermore, this program will become a template for progress as variations on this theme extend beyond infectious disease. The Golden Age of biopharmaceutical technology is upon us, and happily, the FDA assumes the leadership role. Kudos!
    24 May 2014, 03:13 AM Reply Like
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