ETON - Eton Pharmaceuticals Announces Submission to FDA of New Drug Application for ET-400 (Hydrocortisone Oral Solution) | Benzinga
- Company anticipates 10-month review for potential approval in Q1 2025 -
- Eton expects ET-400 and Alkindi Sprinkle® to achieve potential combined peak sales of more than $50 million annually -
- Product has patent protection through 2043 -
DEER PARK, Ill., April 30, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc ("Eton" or the "Company") (NASDAQ:ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of ET-400, Eton's proprietary patented formulation of hydrocortisone oral solution. The Company expects the application to be assigned a 10-month FDA review, allowing for potential approval and launch in the first quarter of 2025.
"With the completion of the NDA submission for ET-400, we are one step closer to bringing this critical medication to children in need. We continue to see very strong demand from patients, caregivers, and physicians, and are confident that ET-400, once approved, and Alkindi Sprinkle can achieve potential combined peak sales ...