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 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 were up nearly 12% in recent trading.
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