|FDA New Drug Approvals Reach a Seven-Year High in 2011
Jan. 20, 2012
The Food and Drug Administration (FDA) approved 30 new drugs in 2011 compared with 21 the year before, and the highest number approved in one year since 2004. Key notables from the 2011 year include:
- 50% of new drug approvals were for specialty drugs. Many of these specialty drugs represent important advances for patients, including two new drugs for hepatitis C, the first new drug for Hodgkin's lymphoma in 30 years and the first new drug for lupus in 50 years.
- 12 of the 30 drugs were the first drugs approved in their therapeutic class.
- Two drugs are novel targeted cancer drugs: one for melanoma and another for lung cancer that were approved with diagnostic tests - approvals that represent breakthroughs in personalized medicine.
- Half of the new drugs approved in 2011 received priority review, which is based on demonstrating a significant benefit over available therapy.
- 10 of the approved drugs were for rare diseases, such as hereditary angioedema.