02:02 PM EST, 12/18/2024 (MT Newswires) -- Theratechnologies ( THTX ) said Wednesday it submitted a prior approval supplement to the US Food and Drug Administration regarding changes made to Egrifta SV manufacturing facility.
The FDA reviews a prior approval supplement within four months and approval is required before distribution of recently manufactured batches of Egrifta, according to the company.
Theratechnologies ( THTX ) said that existing inventory will cover patient demand until mid-January and it plans to continue discussions with the regulator to accelerate the release of the medicine to avoid product shortage for patients.
Shares of Theratechnologies ( THTX ) were up nearly 12% in recent trading.
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