Eton Pharmaceuticals Announces FDA Acceptance of NDA Response for Dehydrated Alcohol Injection

Rhea-AI Summary

Eton Pharmaceuticals (ETON) announced the FDA's acceptance of its New Drug Application (NDA) for dehydrated alcohol injection, aimed at treating methanol poisoning. The application has a PDUFA date set for June 27, 2023. Previously granted orphan drug designation, this product could provide Eton with seven years of exclusivity upon approval. The pharmaceutical market for dehydrated alcohol injection is significant, with trailing twelve-month sales reaching $74 million.

Positive

• FDA acceptance of NDA for dehydrated alcohol injection for methanol poisoning treatment.
• Potential seven years of orphan drug exclusivity upon approval.
• Market potential evidenced by $74 million in trailing twelve-month sales.

Negative

• None.

-- Product previously granted orphan drug designation for methanol poisoning --
-- Application assigned a PDUFA date of June 27, 2023 --

DEER PARK, Ill., Jan. 11, 2023 (GLOBE NEWSWIRE) -- 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 Pharmaceuticals
Eton 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: 212-452-2793
E: lwilson@insitecony.com

Source: Eton Pharmaceuticals

FAQ

What is Eton Pharmaceuticals' latest FDA news?

Eton Pharmaceuticals announced that the FDA has accepted its NDA for dehydrated alcohol injection for methanol poisoning.

What is the PDUFA date for Eton Pharmaceuticals' new drug application?

The PDUFA date for Eton Pharmaceuticals' NDA is set for June 27, 2023.

What indication does the dehydrated alcohol injection target?

The dehydrated alcohol injection is proposed for the treatment of methanol poisoning.

What are the sales figures for dehydrated alcohol injection?

Trailing twelve-month sales for dehydrated alcohol injection were reported at $74 million.

What exclusivity could Eton Pharmaceuticals gain from the FDA approval?

If approved, Eton Pharmaceuticals expects to receive seven years of orphan drug exclusivity.