Amarin (AMRN) Said No FDA NCE Decision in August Orange Book

September 10, 2012 5:10 PM EDT Send to a Friend
Amarin Corp Plc (NASDAQ: AMRN) said after the close of trading Monday that it does not expect an FDA NCE decision by the next Orange Book, due on our about September 14, 2012.

From the filing:

Typically, the U.S. Food and Drug Administration (FDA) publishes a determination on the exclusivity of recently approved products in a cumulative supplement to its Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book, mid-month in the month following the drug’s approval. Vascepa was approved by the FDA in July 2012.

As previously disclosed, on August 16, 2012, the FDA communicated to Amarin Corporation plc (“Amarin”) that it had not yet made a determination with respect to the regulatory exclusivity of Vascepa and the July 2012 cumulative supplement to the Orange Book published on August 17, 2012 did not include an entry with respect to the regulatory exclusivity of Vascepa.

Based on information available to Amarin as of the filing of this report, including communication with the FDA on September 7, 2012, the FDA has not made a determination with respect to regulatory exclusivity for Vascepa. On or about September 14, 2012, the FDA is expected to publish the August 2012 cumulative supplement to the Orange Book. Based on communication with the FDA on September 7, 2012, Amarin does not anticipate that the August Orange Book Supplement will include an entry with respect to the regulatory exclusivity status of Vascepa/


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