Theratechnologies (TH.TO, THTX) announced the FDA has approved the company's Prior Approval Supplement to the supplemental biologics license application for EGRIFTA SV, or tesamorelin for injection. Tesamorelin for injection is the only treatment approved in the U.S. to reduce excess abdominal fat in adults with HIV and lipodystrophy. Approval of the PAS removes any regulatory requirement for discretionary product release, thereby allowing the company to resume regular distribution of EGRIFTA SV.
"Securing FDA approval of the Prior Approval Supplement for the EGRIFTA SV sBLA closes a chapter of supply uncertainty and we are pleased to return to normal supply conditions," said Paul Lvesque, President and CEO of Theratechnologies.
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