Theratechnologies (TH.TO) on Tuesday said the U.S. Food and Drug Administration (FDA) has approved EGRIFTA SV, or tesamorelin, for injection for release.

EGRIFTA SV is the only treatment approved in the U.S. to reduce excess abdominal fat in adults with HIV and lipodystrophy. The latest approval removes any regulatory requirement for product release, allowing Theratechnologies to resume regular distribution of EGRIFTA SV. The FDA recently approved the new F8 formulation of tesamorelin for injection, which is set to replace EGRIFTA SV and will be marketed in the US as EGRIFTA WR, the company said.

"Securing FDA approval. . . closes a chapter of supply uncertainty and we are pleased to return to normal supply conditions," said Paul Levesque, Theratechnologies chief executive. "Now that we have also obtained approval of EGRIFTA WR, we look forward to transitioning patients to this more convenient formulation, which we have designed to improve the patient experience."

The company's shares were last seen up US$0.02, to US$1.66, in New York pre-market trading.