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.