Theratechnologies Inc. announced that the U.S. Food and Drug Administration has granted approval of a supplemental new drug application (sNDA), filed by its commercial partner, EMD Serono Inc., providing for the revision of the EGRIFTA (tesamorelin for injection) prescribing information, to include storage conditions for the 2 mg vial up to 12 weeks at or below 25 degrees C after dispensing to the patient. Previously, EGRIFTA could only be stored between 2 degrees C and 8 degrees C (36 degrees F and 46 degrees F) until the expiration date.
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- United States Food and Drug Administration Grants Approval to Theratechnologies Inc. for EGRIFTA