Eton Pharmaceuticals (ETON)

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Attention Biotech Investors: Mark Your Calendar For September PDUFA Dates

Eton's In-licensed Pediatric Adrenal Insufficiency Drug Awaits FDA Clearance

Company: Eton Pharma
Type of Application: NDA
Candidate: Alkindi Sprinkle
Indication: pediatric adrenal insufficiency
Date: Sept. 29
Eton acquired U.S. marketing rights to Alkindi Sprinkle from AIM-listed Diurnal Group plc in late March. Alkindi Sprinkle, a taste neutral sprinkle or granule formulation of hydrocortisone, is being evaluated as a replacement therapy for pediatric adrenal insufficiency, including congenital adrenal hyperplasia in patients from birth to less than 17 years of age.

The product, which is approved in Europe, is to be available strengths 0.5mg, 1mg, 2mg, and 5mg to provide pediatric atients with optimal precision and flexibility.

Eton estimates the market opportunity of Alkindi Sprinkle to be $100 million annually.