Eton Pharmaceuticals Announces FDA Acceptance of NDA Response for Dehydrated Alcohol Injection
11 January 2023 - 10:50PM
Eton Pharmaceuticals (“Eton” or “the Company”) (Nasdaq: ETON), an
innovative pharmaceutical company focused on developing and
commercializing treatments for rare diseases, today announced that
the U.S. Food and Drug Administration (FDA) has accepted for review
the Company’s New Drug Application (NDA) response for dehydrated
alcohol injection for the proposed indication of methanol
poisoning. The FDA has assigned a Prescription Drug User Fee Act
(PDUFA) target action date of June 27, 2023.
“We are excited to be one step closer to bringing this much
needed product to patients and we have begun working with our
commercial partner to prepare for a potential near-term launch,”
said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
Eton’s application has previously been granted orphan drug
designation for the indication of methanol poisoning and if
approved, the Company expects the FDA to grant the application
seven years of orphan drug exclusivity. Based on IQVIA data,
trailing twelve month sales for dehydrated alcohol injection were
$74 million.
About Eton PharmaceuticalsEton Pharmaceuticals,
Inc. is an innovative pharmaceutical company focused on developing
and commercializing treatments for rare diseases. The Company
currently has three FDA approved products in ALKINDI SPRINKLE®,
Carglumic Acid tablets, and Betaine Anhydrous for oral solution,
and three late-stage pipeline candidates under development with
dehydrated alcohol injection, ZENEO® hydrocortisone autoinjector,
and ET-400. In addition, the Company receives royalties on three
FDA-approved products and is entitled to receive milestone payments
on other products. For more information, please visit our website
at www.etonpharma.com.
Investor Relations:Lisa M. Wilson, In-Site
Communications, Inc.T: 212-452-2793E: lwilson@insitecony.com
Source: Eton Pharmaceuticals
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