Theratechnologies has received a Complete Response Letter (CRL) from the US FDA on its sBLA of tesamorelin’s F8 formulation for excess abdominal fat reduction in HIV and lipodystrophy patients
The CRL raised concerns regarding chemistry and manufacturing & controls (CMC) incl. microbiology, assays, impurities & stability for both the lyophilized and the final reconstituted drug. The US FDA has also requested data demonstrating the impact of the proposed formulation on immunogenicity risk
The issued CRL does not affect the commercial availability of EGRIFTA SV (F4 formulation of tesamorelin) for excess abdominal fat reduction in adults with HIV and lipodystrophy
Ref: Theratechnologies | Image: Theratechnologies
Related News:- Palisade Bio Reports P-II Study (PROFILE) Results of LB1148 for Post-Surgical Abdominal Adhesions
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
