Plus   Neg

Amarin Says No FDA Advisory Committee Will Be Scheduled For Its AMR101 NDA

Amarin Corporation plc (AMRN) said Monday it has been informed by the U.S. Food and Drug Administration that no advisory committee meeting will be scheduled in connection with the FDA's review of the New Drug Application seeking approval for the use AMR101 in the treatment of patients with very high triglycerides, the company's lead product candidate.

The FDA has previously assigned a Prescription Drug User Fee Act date of July 26, 2012 for completion of its review of the AMR101 NDA.

by RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Follow RTT