In the first 7 months of 2011, the FDA has approved 18 new molecular entity pharmaceutical drugs (and no biologic NMEs)

In the first seven months of 2011 (January 14 to July 20) , the US FDA has already approved 18 new molecular entity drugs. These are some notes on the approvals:

• All of the NME products are considered pharmaceutical drugs, and received approval under FDA procedures for New Drug Applications (NDA).
• Despite the trends indiciating shifts to biologic products from pharmaceutical drugs, none of the 2011 products introduced to date were biologics.
• One third (6 of 18) received Priority review status. 12 of 18 received Standard review status.
• Of the 18 drugs, US based companies owned 9, German and UK companies 3 and one each for Japanese and Swiss firms.
• Of the companies that received approval this year, Johnson and Johnson developed 3, AstraZeneca 2, Bayer 2 and Forest Labs 2. Ten more companies developed 1 drug each.
• Uses for these drugs were varied. Two (Zytiga and Vandetanib) are for cancer. Additionally, there are two drugs approved to treat COPD (Arcapta and Daliresp) and hepatitis C (Victrelis and Incivek), and two anticonvulsants (Horizant and Xarelto). There is 1 new HIV treatment (Edurant)

2011 FDA New Molecular Entity Approvals, January – July