Assertio Therapeutics Announces FDA Notification of Acceptance for Filing of 505(b)(2) NDA for Long-acting Cosyntropin
“We are pleased to announce another positive milestone in the development of long-acting cosyntropin and in the advancement of our strategy to build a new orphan/specialty business,” said
The PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA’s review of long-acting cosyntropin is set for
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.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
This news release contains forward-looking statements. These statements involve inherent risks and uncertainties that could cause actual results to differ materially from those projected or anticipated, including risks related to regulatory approval and clinical development of long-acting cosyntropin, expectations regarding potential business opportunities and other risks outlined in the Company's public filings with the
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Source: Assertio Therapeutics, Inc.
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