Theratechnologies Has Submitted A Prior Approval Supplement To The U.S. FDA Describing The Changes Made To The Manufacturing Environment Of The Facility Where EGRIFTA SV Is Produced

Benzinga · Dec 19 02:33

Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX:TH) (NASDAQ:THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that the Company has submitted a Prior Approval Supplement (PAS) to the U.S. Food and Drug Administration (FDA) describing the changes made to the manufacturing environment of the facility where EGRIFTA SV is produced. A PAS is reviewed by the FDA within four months of receipt and an approval is needed prior to the distribution of the recently manufactured batches of EGRIFTA SV.

Existing inventory levels of EGRIFTA SV are expected to meet patient demand until mid-January 2025. Theratechnologies therefore continues discussions with the relevant FDA divisions in an effort to accelerate the release of EGRIFTA SV and avoid a product shortage at the patient level.

The Company will update the market on any further material developments.

EGRIFTA SV is distributed in the United States only.

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Theratechnologies Has Submitted A Prior Approval Supplement To The U.S. FDA Describing The Changes Made To The Manufacturing Environment Of The Facility Where EGRIFTA SV Is Produced

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