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Eton Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Orphan Drug Dehydrated Alcohol Injection

Eton Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Orphan Drug Dehydrated Alcohol Injection

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 
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