Eton Pharmaceuticals Announces Acceptance for Filing of New Drug Application
for Orphan Drug Dehydrated Alcohol Injection
- Application Assigned a PDUFA Date of May 27, 2021
- Dehydrated Alcohol Injection Market Estimated to be Greater Than $100
Million Annually
- Application has Received Orphan Drug Designation for Methanol Poisoning
DEER PARK, Ill., Oct. 08, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc
(Nasdaq: ETON), a specialty pharmaceutical company focused on developing and
commercializing innovative treatments for rare pediatric diseases, today
announced the U.S. Food and Drug Administration (FDA) has accepted for filing
the company’s new drug application (NDA) for dehydrated alcohol injection. The
application has been assigned a Prescription Drug User Fee Act (PDUFA) date of
May 27, 2021.
Eton’s application previously received orphan drug designation for the
treatment of methanol poisoning and is expected to receive seven years of
market exclusivity upon its approval.
The U.S. market for dehydrated alcohol injection is estimated to be greater
than $100 million annually and the drug is currently only supplied by a single
manufacturer^1.
About Eton Pharmaceuticals
Eton Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on
developing and commercializing innovative treatments for rare pediatric
diseases. The company currently owns or receives royalties from three
FDA-approved approved products, including ALKINDI® SPRINKLE, Biorphen®, and
Alaway® Preservative Free, and has six additional products in its late-stage
pipeline, including five that have been submitted to the FDA.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not
historical facts are "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995, including statements
associated with the expected ability of Eton to undertake certain activities
and accomplish certain goals and objectives. These statements include but are
not limited to statements regarding Eton’s business strategy, Eton’s plans to
develop and commercialize its product candidates, the safety and efficacy of
Eton’s product candidates, Eton’s plans and expected timing with respect to
regulatory filings and approvals, and the size and growth potential of the
markets for Eton’s product candidates. Because such statements are subject to
risks and uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Words such as
"believes," "anticipates," "plans," "expects," "intends," "will," "goal,"
"potential" and similar expressions are intended to identify forward-looking
statements. These forward-looking statements are based upon Eton’s current
expectations and involve assumptions that may never materialize or may prove
to be incorrect. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking statements as a
result of various risks and uncertainties, which include, without limitation,
risks associated with the process of discovering, developing and
commercializing drugs that are safe and effective for use as human
therapeutics, and in the endeavor of building a business around such drugs.
These and other risks concerning Eton’s development programs and financial
position are described in additional detail in Eton’s filings with the
Securities and Exchange Commission. All forward-looking statements contained
in this press release speak only as of the date on which they were made. Eton
undertakes no obligation to update such statements to reflect events that
occur or circumstances that exist after the date on which they were made.
^1Based on IQVIA data’s average of 130,928 units annually from 2016-2019 and
the current market WAC price of $995 per unit
Company Contact:
David Krempa
dkrempa@etonpharma.com
612-387-3740
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