Eton Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Orphan Drug Dehydrated Alcohol Injection
Eton Pharmaceuticals, Inc. announced that the FDA has accepted its new drug application (NDA) for dehydrated alcohol injection, with a PDUFA date set for May 27, 2021. The drug, which is crucial for treating methanol poisoning, has received orphan drug designation, ensuring seven years of market exclusivity upon approval. The U.S. market for this injection is estimated to exceed $100 million annually, currently supplied by only one manufacturer. Eton focuses on developing innovative treatments for rare pediatric diseases and has multiple products in its late-stage pipeline.
- FDA acceptance of NDA for dehydrated alcohol injection with PDUFA date of May 27, 2021.
- Application received orphan drug designation for methanol poisoning, ensuring seven years of market exclusivity.
- Significant market potential with an estimated annual revenue exceeding $100 million.
- None.
- Application Assigned a PDUFA Date of May 27, 2021
- Dehydrated Alcohol Injection Market Estimated to be Greater Than
- 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
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.
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1Based on IQVIA data’s average of 130,928 units annually from 2016-2019 and the current market WAC price of
Company Contact:
David Krempa
dkrempa@etonpharma.com
612-387-3740
