Complete Response Letter for injectable formulation of long-acting cosyntropin treatment for adrenocortical insufficiency.- Assertio Therapeutics
Assertio Therapeutics, Inc. announced that its development partner West Therapeutic Development, LLC (West) has received a Complete Response Letter (CRL) from the FDA for its New Drug Application (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 CRL relates to the FDA determination that certain pharmacodynamic parameters were not adequately achieved.
Long-acting cosyntropin is an alcohol-free formulation of a synthetic analogue of ACTH, a hormone secreted from the pituitary gland that is responsible for the stimulation of the adrenal cortex. Cosyntropin is composed of the first 24 of 39 amino acids of natural ACTH and retains the full steroidogenic activity of natural ACTH..
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