Posted by Michael Wonder on 23 Dec 2018
Assertio Therapeutics announces submission of NDA for FDA approval of cosyntropin depot
20 December 2018 - Submission advances company’s strategy to build a new orphan/specialty business and aligns with company’s mission of putting patients first.
Assertio Therapeutics today announced that it has submitted to the U.S. FDA a 505(b)(2) new drug application for its novel injectable formulation of cosyntropin (synthetic adrenocorticotropic hormone, or ACTH) depot with its partner, West Therapeutic Development, LLC. The application seeks approval for the use of this product as a diagnostic drug in the screening of patients presumed to have adrenocortical insufficiency.
Cosyntropin depot is an alcohol-free formulation of a synthetic ACTH analogue, a hormone secreted from the pituitary gland that is responsible for the stimulation of the adrenal cortex. Cosyntropin depot is composed of the first 24 of 39 amino acids found in ACTH, which retains the full steroidogenic activity of the natural hormone.
