Alimera Sciences has resubmitted its New Drug Application (NDA) for its fluocinolone acetonide intravitreal implant (Iluvien) to the FDA.
Atlanta-Alimera Sciences has resubmitted its New Drug Application (NDA) for its fluocinolone acetonide intravitreal implant (Iluvien) to the FDA.
In the resubmission, Alimera responded to questions raised in the FDA’s October 2013 complete response letter and provided a safety update, which included commercial experience with the product-a treatment for chronic diabetic macular edema-in Europe.
Now, the company must await the FDA’s acceptance of the resubmission and a prescription drug user fee act (PDUFA) date.
“We are pleased to resubmit (the sustained-release intravitreal implant) for approval in the United States,” said Dan Myers, Alimera’s president and chief executive officer. “We look forward to an acknowledgement from the FDA that the response is complete and that a PDUFA has been confirmed.”
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