Theratechnologies Announces Filing of FDA Prior Approval Supplement for EGRIFTA SV® Manufacturing Environment

Core Viewpoint - Theratechnologies Inc. has submitted a Prior Approval Supplement (PAS) to the FDA regarding changes in the manufacturing environment for EGRIFTA SV®, which is necessary for the distribution of recently manufactured batches [1] Group 1: Manufacturing and Regulatory Updates - The PAS will be reviewed by the FDA within four months, and approval is required before distributing the new batches of EGRIFTA SV® [1] - The company is in discussions with the FDA to expedite the release of EGRIFTA SV® to prevent a product shortage for patients [2] Group 2: Product Availability - Existing inventory levels of EGRIFTA SV® are projected to meet patient demand until mid-January 2025 [2] - EGRIFTA SV® is exclusively distributed in the United States [4] Group 3: Company Information - Theratechnologies focuses on developing and commercializing innovative therapies to address unmet medical needs [5]