Posted by Michael Wonder on 02 May 2018
FDA releases Theratechnologies from post-approval commitments related to Egrifta (tesamorelin for injection)
1 May 2018 - Theratechnologies today announced that the FDA has released Theratechnologies from post-approval commitments related to the approval of Egrifta.
At the time of approval of Egrifta on 10 November 2010, the FDA requested that the company conduct two large safety clinical trials.
The FDA determined that these two large-scale post-approval clinical trials are no longer required as the current labelling adequately reflects the safety profile of Egrifta. The FDA also concluded that the size of the HIV patient population with lipodystrophy did not make such a requirement feasible.
