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
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
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.
專注於創新療法開發和商業化的生物製藥公司Theratechnologies Inc.（「Theratechnologies」 或 「公司」）（多倫多證券交易所股票代碼：TH）（納斯達克股票代碼：THTX）今天宣佈，該公司已向美國食品藥品監督管理局（FDA）提交了事先批准補充文件（PAS），描述了對生產EGRIFTA SV的設施的製造環境所做的更改。食品和藥物管理局在收到PAS後的四個月內對PAS進行審查，在分發最近生產的EGRIFTA SV批次之前，需要獲得批准。
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.
預計EGRIFTA SV的現有庫存水平將在2025年1月中旬之前滿足患者的需求。因此，Theratechnologies繼續與美國食品藥品管理局的相關部門進行討論，以加快EGRIFTA SV的發佈並避免患者層面的產品短缺。
The Company will update the market on any further material developments.
該公司將向市場通報任何進一步的重大進展。
EGRIFTA SV is distributed in the United States only.
EGRIFTA SV 僅在美國發行。