Flamel Technologies S.A. (FLML) Monday said it has received a Prescription Drug User Fee Act date of August 6, 2014 from the U.S. Food and Drug Administration or FDA , for its second New Drug Application or NDA for an Unapproved Marketed Drug.
Earlier, the company had received a Complete Response Letter to its NDA on April 28. After re-submission of NDA on June 6, FDA classified the CRL resubmission as a Class 1 response.
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