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U.S. Department of Health and Human Services

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FY 2012 Innovative Drug Approvals

FY 2012 Innovative Drug Approvals report cover image

Correction issued (page 25) and revised report posted 12/10/12.

In fiscal year 2012, FDA continued to bring innovative drugs to patients in the United States quickly and efficiently, while ensuring that medicines are safe and effective.

FDA used expedited approval authorities and flexibility in advising sponsors on clinical trial design to approve 35 novel drugs in FY 2012. 

Among the 35 novel drugs approved in FY 2012 are important advancements for patients, including a groundbreaking treatment for a form of cystic fibrosis (approved in only 3.5 months), the first FDA-approved human cord blood product, and the first drugs to treat advanced basal cell carcinoma (a form of the most common skin cancer) and the bone marrow disease myelofibrosis. The FDA also continued its commitment to approving drugs for patients with rare (orphan) diseases.

As part of the FDA’s focus on advancing regulatory science, the agency is helping to streamline early phase drug development such as with the new breakthrough pathway, which will assist with getting innovative new drugs to patients.

Read the report