Theratechnologies Announces Filing of FDA Prior Approval Supplement for EGRIFTA SV® Manufacturing Environment
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Theratechnologies Inc. has filed a Prior Approval Supplement with the FDA for changes in the manufacturing environment of EGRIFTA SV®. The FDA review is expected within four months, and approval is required before distribution of new batches.
December 18, 2024 | 6:45 pm
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Theratechnologies has submitted a Prior Approval Supplement to the FDA for changes in the manufacturing environment of EGRIFTA SV®. Approval is required before distributing new batches.
The submission of a Prior Approval Supplement to the FDA is a significant regulatory step for Theratechnologies. While it does not immediately impact the stock price, the outcome of the FDA review could influence future distribution and sales of EGRIFTA SV®, affecting the company's financial performance.
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