Theratechnologies CRL for F8 Formulation of Tesamorelin sBLA

 

• FDA requesting clarifications around chemistry, manufacturing and controls and additional information related to immunogenicity
• CRL does not impact commercial availability of EGRIFTA SV^®, the F4 formulation of tesamorelin, the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV and lipodystrophy

https://www.biospace.com/article/releases/theratechnologies-receives-complete-response-letter-crl-from-the-fda-for-the-f8-formulation-of-tesamorelin-sbla/