Alimera resubmits NDA for Iluvien
US ophthalmic pharma specialist Alimera Sciences (Nasdaq: ALIM) has resubmitted its New Drug Application for Iluvien (fluocinolone acetonide intravitreal implant) to the US Food and Drug Administration.
In the resubmission, Alimera responded to questions raised in the FDA’s October 2013 complete response letter (The Pharma Letter October 18, 2013) and provided a safety update, which included commercial experience with Iluvien in Europe.
Dan Myers, Alimera's president and chief executive, said: “We are pleased to resubmit Iluvien for approval in the United States. We look forward to an acknowledgment from the FDA that the response is complete and that a PDUFA date has been confirmed.”
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