Posted by Michael Wonder on 21 Oct 2019
Assertio Therapeutics provides regulatory update on long-acting Cosyntropin
21 October 2019 - Assertio Therapeutics today announced that its development partner West Therapeutic Development has received a complete response letter from the U.S. FDA for its NDA for its injectable formulation of long-acting cosyntropin (synthetic adrenocorticotropic hormone, or ACTH).
West is seeking approval for use as a diagnostic drug in the screening of patients presumed to have adrenocortical insufficiency.
The primary focus of the letter relates to the FDA determination that certain pharmacodynamic parameters were not adequately achieved.
