Assertio Therapeutics Provides Regulatory Update on Long-Acting Cosyntropin
Assertio Holdings, Inc. (ASRT)
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Source: GlobeNewswire
LAKE FOREST, Ill., Oct. 21, 2019 (GLOBE NEWSWIRE) -- Assertio Therapeutics, Inc. (NASDAQ: ASRT), today announced that its development partner West Therapeutic Development, LLC (West) has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (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. “West and Assertio will work together to determine how best to address the CRL,” said Arthur Higgins, President and CEO of Assertio. “In the meantime, we continue to focus on driving robust adjusted EBITDA performance and generating strong cash flows.” Long-acting cosyntropin is an alcohol-free formulation of
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