ETON - Eton says FDA accepted resubmitted NDA for methanol poisoning candidate
- Eton Pharmaceuticals ( NASDAQ: ETON ) announced Wednesday that the FDA accepted its new drug application (NDA) response for dehydrated alcohol injection as a treatment for methanol poisoning.
- The agency has granted June 27, 2023, as the PDUFA target action date for its decision.
- “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,” Chief Executive Sean Brynjelsen remarked.
- The FDA has granted orphan drug designation for the candidate in methanol poisoning, and if approved, the company will enjoy seven years of orphan drug exclusivity for the product.
- Citing IQVIA data, Eton ( ETON ) says the last twelve-month sales for dehydrated alcohol injections stood at $74M.
- In May 2021, the FDA issued a so-called complete response to the company declining to approve the product.
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Eton says FDA accepted resubmitted NDA for methanol poisoning candidate