Eton Pharmaceuticals Announces FDA Acceptance of NDA Response for Dehydrated Alcohol Injection
Eton Pharmaceuticals, Inc. (ETON)
Last eton pharmaceuticals, inc. earnings: 3/5 04:02 pm
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Source: GlobeNewswire
-- 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
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ETON
Earnings
- 3/14/24 - Miss
ETON
Sec Filings
- 4/18/24 - Form 8-K
- 3/26/24 - Form S-8
- 3/22/24 - Form 10-K/A
- ETON's page on the SEC website