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）（纳斯达克:THTX），是一家专注于创新疗法开发和商业化的生物制药公司，今天宣布公司已向美国食品药品监督管理局（FDA）提交了一份优先批准补充申请（PAS），描述了EGRIFTA SV生产设施制造环境的变化。FDA将在收到申请后四个月内对此进行审查，且在分发最近生产的EGRIFTA SV批次之前需要获得批准。
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.
预计EGRIFTA SV的现有库存水平将满足患者需求，直到2025年1月中旬。因此，Theratechnologies继续与相关的FDA部门进行讨论，以加快EGRIFTA SV的发布，避免在患者层面出现产品短缺。
The Company will update the market on any further material developments.
公司将就进一步的重大进展更新市场。
EGRIFTA SV is distributed in the United States only.
EGRIFTA SV仅在美国销售。