FDA approves alternative storage conditions for EGRIFTA™
FDA approves alternative storage conditions for EGRIFTA™
Jan 21, 2013
Supporting Materials:
Theratechnologies Inc. (TSX: TH) (NASDAQ: THER) announced today that the U.S. Food and Drug Administration (FDA) has granted approval of a Supplemental New Drug Application (sNDA), filed by its commercial partner, EMD Serono, Inc., providing for the revision of the EGRIFTATM (tesamorelin for injection) prescribing information, to include storage conditions for the 2 mg vial up to 12 weeks at or below 25°C after dispensing to the patient.