Posted by Michael Wonder on 05 Jul 2018
Theratechnologies submits novel single-vial formulation of Egrifta (tesamorelin for injection) for FDA approval
4 July 2018 - Theratechnologies today announced that it has filed a supplemental new drug application with the FDA for a single-vial formulation of Egrifta.
The filing is based on bioequivalence studies which were completed earlier this year. The new single-vial formulation, known as “F4”, is four times more concentrated than the currently commercialised formulation of Egrifta. The F4 significantly reduces the volume of administration and handling is more user-friendly as it comes in a single vial instead of two.
Furthermore, the F4 is stable at room temperature which represents an advantage as Egrifta now requires a cold-chain distribution network from the manufacture to the patient.
