Brief: Theratechnologies Says CRL Does Not Impact Commercial Availability Of EGRIFTA SV
24/01/2024 12:11
Jan 24 (Reuters) - Theratechnologies Inc TH.TO :
* THERATECHNOLOGIES RECEIVES COMPLETE RESPONSE LETTER (CRL)
FROM
THE FDA FOR THE F8 FORMULATION OF TESAMORELIN SBLA
* THERATECHNOLOGIES - FDA REQUESTING CLARIFICATIONS AROUND
CHEMISTRY, MANUFACTURING AND CONTROLS AND ADDITIONAL INFORMATION
RELATED TO IMMUNOGENICITY
* THERATECHNOLOGIES INC - CRL DOES NOT IMPACT COMMERCIAL
AVAILABILITY OF EGRIFTA SV
* THERATECHNOLOGIES INC - COMPANY WILL ADDRESS FDA'S REQUEST
AND
INTENDS TO PURSUE APPROVAL OF THIS NEWER FORMULATION OF
TESAMORELIN
* THERATECHNOLOGIES INC - COMPANY WILL CONTINUE TO
COMMERCIALIZE
EGRIFTA SV
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