Theratechnologies Inc. (TH.TO,THTX) announced the FDA has issued a Complete Response Letter in response to the company's supplemental Biologics License Application for the F8 formulation of tesamorelin. The company said it will address the FDA's request. The company noted that the questions outlined in the CRL are largely related to chemistry, manufacturing and controls concerning the microbiology, assays, impurities and stability for both the lyophilized product and the final reconstituted drug product.
"While we are disappointed to receive a Complete Response Letter from the FDA for the F8 formulation of tesamorelin containing questions that were not raised during the review process, we plan to address these new comments as swiftly as possible," said Christian Marsolais, Chief Medical Officer at Theratechnologies.
Shares of Theratechnologies are down 27% in pre-market trade on Wednesday.
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