Assertio Therapeutics Announces FDA Notification of Acceptance for Filing of 505(b)(2) NDA for Long-acting Cosyntropin
February 19 2019 - 8:30AM
Assertio Therapeutics, Inc. (NASDAQ: ASRT) announced today that it
has received notification of acceptance for filing from the U.S.
Food and Drug Administration (FDA) for its 505(b)(2) New Drug
Application for its injectable formulation of long-acting
cosyntropin (synthetic adrenocorticotropic hormone, or ACTH). The
Company, together with its partner West Therapeutic Development,
seeks approval for the use of this product as a diagnostic drug in
the screening of patients presumed to have adrenocortical
insufficiency.
“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 Arthur
Higgins, President and Chief Executive Officer of Assertio. “The
FDA’s acceptance of our filing positions us one step closer to
launching a synthetic long-acting cosyntropin into the U.S. market
by early 2020.”
The PDUFA (Prescription Drug User Fee Act) goal date for the
completion of the FDA’s review of long-acting cosyntropin is set
for October 19, 2019. This date reflects a standard 10-month review
period and is consistent with management’s expectations for the
505(b)(2) filing.
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.
About Assertio Therapeutics, Inc.Assertio
Therapeutics is committed to providing responsible solutions to
advance patient care in the Company’s core areas of neurology,
orphan and specialty medicines. Assertio currently markets three
FDA-approved products and continues to identify, license and
develop new products that offer enhanced options for patients that
may be underserved by existing therapies. To learn more about
Assertio, visit www.assertiotx.com.
"Safe Harbor" Statement under the Private Securities
Litigation Reform Act of 1995This 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 Securities and Exchange Commission, including the
Company's most recent annual report on Form 10-K and subsequent
Quarterly Reports on Form 10-Q. All information provided in this
news release speaks as of the date hereof. Except as otherwise
required by law, the Company undertakes no obligation to update or
revise its forward-looking statements.
Investor and Media Contact:John B. Thomas SVP,
Investor Relations and Corporate Communications
jthomas@assertiotx.com
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