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.
Price: 1.81, Change: +0.19, Percent Change: +11.67
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.