Alimera Sciences Confirms ILUVIEN NDA Resubmission Has Been Accepted by the FDA
By Louis Bedigian
Benzinga Staff Writer
June 01, 2011 11:41 AMSymbols: PSDV, ALIM
Tags: alimera sciences, ILUVIEN, Alimera, pSivida
Less than one hour before the close yesterday, Benzinga heard positive rumors that the NDA for ILUVIEN, which was resubmitted roughly two weeks ago, had been accepted by the Food and Drug Administration.
The drug, which is a joint venture between pSivida (NASDAQ: PSDV) and Alimera Sciences (NASDAQ: ALIM), was originally rejected by the FDA in January.
This morning, a spokeswoman for Alimera confirmed to Benzinga that the NDA resubmission for ILUVIEN has been accepted by the FDA. The spokeswoman said that Alimera submitted a revised NDA with new data, and that the FDA has until November 12 to examine the revised application.
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