Theratechnologies Announces Filing of FDA Prior Approval Supplement for EGRIFTA SV® Manufacturing Environment
Theratechnologies Inc. - Common Shares (THTX)
Company Research
Source: GlobeNewswire
MONTREAL, Dec. 18, 2024 (GLOBE NEWSWIRE) -- 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.
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- Theratechnologies Announces Filing of FDA Prior Approval Supplement for EGRIFTA SV® Manufacturing Environment [Canadian Business Journal (Canada)]Canadian Business Journal
- Theratechnologies Receives March 2025 PDUFA Goal Date for Updated Tesamorelin F8 Formulation sBLA [Canadian Business Journal (Canada)]Canadian Business Journal
- Theratechnologies Receives March 2025 PDUFA Goal Date for Updated Tesamorelin F8 Formulation sBLAGlobeNewswire
- Theratechnologies Announces Preliminary Tolerability and Efficacy Data from Phase 1b, Dose-Ranging Trial of Sudocetaxel Zendusortide in Patients with Advanced Ovarian Cancer [Yahoo! Finance]Yahoo! Finance
- Theratechnologies Announces Preliminary Tolerability and Efficacy Data from Phase 1b, Dose-Ranging Trial of Sudocetaxel Zendusortide in Patients with Advanced Ovarian CancerGlobeNewswire
THTX
Sec Filings
- 12/19/24 - Form 6-K
- 12/12/24 - Form 6-K
- 12/11/24 - Form 6-K
- THTX's page on the SEC website