Theratechnologies (TSX:TH; NASDAQ:THTX) announced that the FDA has granted approval for the company to resume U.S. distribution of its tesamorelin injection, EGRIFTA SV, for patients with HIV.
According to the company, two recently manufactured batches of EGRIFTA SV will be released and are ready for immediate shipment to network pharmacies. The FDA’s review of Theratechnologies’ prior approval supplement is ongoing, with an action goal date of April 18, 2025.
“We remain committed to providing EGRIFTA SV to people with HIV and we truly appreciate the FDA’s collaboration to get the treatment back to the patients who rely on it,” said Christian Marsolais, Ph.D., SVP and CMO at Theratechnologies.
