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

Eton Pharmaceuticals Inc 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.

Source: Eton Pharmaceuticals

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