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FDA: 35 Innovative New Drugs Approved in Fiscal Year 2011
Date:11/3/2011

e notable for their advances in patient care and for the efficiency with which they were approved:

  • Two of the drugs – one for melanoma and one for lung cancer – are breakthroughs in personalized medicine. Each was approved with a diagnostic test that helps identify patients for whom the drug is most likely to bring benefits;
  • Seven of the new medicines provide major advances in cancer treatment;
  • Almost half of the drugs were judged to be significant therapeutic advances over existing therapies for heart attack, stroke and kidney transplant rejection;
  • Ten are for rare or "orphan" diseases, which frequently lack any therapy because of the small number of patients with the condition, such as a treatment for hereditary angioedema;
  • Almost half (16) were approved under "priority review," in which the FDA has a six month goal to complete its review for safety and effectiveness;
  • Two-thirds of the new approvals were completed in a single review cycle, meaning sufficient evidence was provided by the manufacturer so that the FDA could move the application through the review process without requesting major new information;
  • Three were approved using "accelerated approval," a program under which the FDA approves safe and effective medically important new drugs quickly, and relies on subsequent post-market studies to confirm clinical benefit. For example, Corifact, the first treatment approved for a rare blood clotting disorder, was approved under this program; and
  • Thirty-four of 35 were approved on or before the review time targets agreed to with industry under PDUFA, including three cancer drugs that FDA approved in less than six months.

The Prescription Drug User Fee Act was established by Congress in 1992 to ensure that the FDA had the necessary resources for the safe and timely review of new drugs and for increased drug safety efforts. The current
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SOURCE U.S. Food and Drug Administration
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