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Theratechnologies Submits FDA Prior Approval Supplement for Egrifta Manufacturing Changes
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Theratechnologies Submits FDA Prior Approval Supplement for Egrifta Manufacturing Changes
Dec 18, 2024 11:30 AM

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.

Price: 1.81, Change: +0.19, Percent Change: +11.67

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