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Thursday, May 16, 2013 3:55:51 PM
Dear Williams,
As previously stated, no further information is available from FDA at this time regarding exclusivity for Vascepa.
Best regards,
B.C.
Drug Information Specialist | Division of Drug Information
Center for Drug Evaluation and Research | Food and Drug Administration
For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at FDA_Drug_Info
This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed
------------
Prior emails have stated no decision has been made...so I assume yes a decision has been made but we're not telling you;)
Response from an April 25th email:
Dear Williams,
Thank you for writing the Food and Drug Administration. Your inquiry was forwarded to the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research (CDER) for a direct reply.
The Agency is currently reviewing Amarin Pharma, Inc.'s request that FDA grant 5-year new chemical entity (NCE) exclusivity for Vascepa. No further information is available from FDA at this time regarding exclusivity for Vascepa.
Best regards,
B.C.
Drug Information Specialist | Division of Drug Information
Center for Drug Evaluation and Research | Food and Drug Administration
For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at FDA_Drug_Info
This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed
Someone post to twits cause they've mentioned it.
Williams
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