TH Theratechnologies Inc

By Colin Kellaher

The U.S. Food and Drug Administration has rejected an application from Theratechnologies seeking approval of a newer formulation of its Egrifta drug.

Theratechnologies on Wednesday said the FDA issued a so-called complete response letter, indicating the agency won't approve the application in its current form and requesting clarifications around chemistry, manufacturing and controls.

The Montreal-based company said the FDA is also seeking additional information related to immunogenicity, adding that it plans to address the FDA's request and continue to pursue approval of the new formulation.

Theratechnologies said the rejection doesn't affect the commercial availability of Egrifta SV, the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV and lipodystrophy.

Trading in U.S.-listed shares of Theratechnologies, which closed Tuesday at $1.72, was halted premarket on Wednesday.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

January 24, 2024 07:34 ET (12:34 GMT)

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