New PDUFA date for Alimera’s Iluvien

Atlanta-Alimera Sciences’ recent resubmission of the new drug application (NDA) for its fluocinolone acetonide intravitreal implant (Iluvien) has been received by the FDA as a complete class 2 response to the agency’s October letter, and a prescription drug user fee act (PDUFA) goal date of Sept. 26 has been established.

In the resubmission, Alimera responded to questions raised in the FDA’s October letter, and provided data from patient and physician experiences with the applicator in the United Kingdom and Germany, where the product is currently commercially available.

“We are pleased to have achieved our goal of resubmitting our NDA in the first quarter and to have a PDUFA goal date set for a decision from the FDA,” said Dan Myers, Alimera’s president and chief executive officer. “We look forward to the FDA’s response to our NDA and hope that we will be able to make (the applicator) available to patients in the United States who are suffering from chronic diabetic macular edema.”

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