Core Viewpoint - Theratechnologies Inc. has resumed the production of EGRIFTA SV® after a voluntary shutdown due to FDA inspection observations, and is working to ensure market availability and avoid patient shortages in 2025 [1][3]. Group 1: Production and Quality Control - The production of EGRIFTA SV® has resumed, and one newly manufactured batch has completed quality control, pending FDA approval for market release [2]. - Two additional batches of EGRIFTA SV® are currently in production [2]. - The company is managing existing inventory levels to meet patient demand until mid-January 2025 [2]. Group 2: Regulatory Collaboration - Theratechnologies is collaborating closely with the FDA and other stakeholders to prevent a shortage of EGRIFTA SV® at the patient level in 2025 [3]. Group 3: Future Updates - The company will provide updates on any further material developments regarding EGRIFTA SV® [4].
Theratechnologies Announces Resumed Production of EGRIFTA SV®