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.
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SCP 16: Summary by the Chair


WIPO
World Intellectual Property Organization

SCP/16/8 PROV.
ORIGINAL: ENGLISH
DATE: MAY 20, 2011

Standing Committee on the Law of Patents

Sixteenth Session
Geneva, May 16 to 20, 2011

SUMMARY BY THE CHAIR

Agenda Item 1: Opening of the session

1. The sixteenth of the Standing Committee on the Law of Patents (SCP) was opened by Mr. James Pooley, Deputy Director General, who welcomed the participants. Mr. Philippe Baechtold (WIPO) acted as Secretary.

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