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

Written by Customer Service on . Posted in Public Companies.

– 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 PoisoningDEER 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 manufacturer1.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.Company Contact:
David Krempa
dkrempa@etonpharma.com
612-387-3740

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