FDA New drug approvals for 2011, through June 6
This is a report from the FDA on 2011 new molecular entities (NMEs) approvals, through June 6, 2011. The total number of FDA approvals during that same period was 150. So far, 16 NMEs have been approved in five months, a sharp increase in approvals over the same period 2010.
6 NMEs NDAs were considered priorities
8 NDAs that were considered standard approvals
2 BLA (biologic products) that were not classified.
- NMEs were 10.7 percent of all approvals.
- The NME priority NDAs were 4 percent of FDA approvals.
On Thursday, May 26, 2011, Senator Bernie Sanders (I-VT) introduced two bills in the United States Senate that would de-link R&D costs from drug prices. The bill names and numbers are as follows:
AIDS Drug Assistance Programs (ADAP) are state run programs that provide medicines to low-income HIV-positive patients who either have limited or no insurance coverage. ADAPs are essential in providing life-saving medicines to low-income patients, but these programs are threatened by the high costs of treatment.