FDA releases Theratechnologies from EGRIFTA post-approval commitments
The FDA has released Theratechnologies (TSX:TH) from post-approval commitments related to the approval of EGRIFTA.
When the FDA approved EGRIFTA in 2010, the agency requested that the company conduct two large safety clinical trials.
In a statement, Theratechnologies said the FDA has determined that the two large-scale post-approval clinical trials are no longer required as the current labeling 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.
Theratechnologies said it had estimated that the post-approval commitments would require an additional investment of $13-million, which will no longer be required.