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.
Theratechnologies Inc.（"Theratechnologies"或"公司"）（TSX:TH）（納斯達克:THTX），是一家專注於創新療法開發和商業化的生物製藥公司，今天宣佈公司已向美國食品藥品監督管理局（FDA）提交了一份優先批准補充申請（PAS），描述了EGRIFTA SV生產設施製造環境的變化。FDA將在收到申請後四個月內對此進行審查，且在分發最近生產的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的現有庫存水平將滿足患者需求，直到2025年1月中旬。因此，Theratechnologies繼續與相關的FDA部門進行討論，以加快EGRIFTA SV的發佈，避免在患者層面出現產品短缺。
The Company will update the market on any further material developments.
公司將就進一步的重大進展更新市場。
EGRIFTA SV is distributed in the United States only.
EGRIFTA SV僅在美國銷售。
譯文內容由第三人軟體翻譯。