Eton Pharmaceutical's Alkindi Sprinkle (hydrocortisone) Receives US FDA's Approval as Replacement Therapy in Pediatric Patients
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- The approval is based on 6 clinical studies- including the 1st and only interventional P-lll study which involves the assessing of Alkindi Sprinkle (hydrocortisone) for Pediatric AI in neonates to children under 8 yrs. of age
- Eton expects Alkindi Sprinkle to be commercially available in the Q4’ 2020 and it will be available in four strengths: 0.5mg- 1mg- 2mg- and 5mg- to give greater dosing flexibility to clinicians
- Alkindi Sprinkle is the 1st and only FDA-approved granular hydrocortisone formulation for the treatment of adrenocortical insufficiency specifically designed for use in children
Ref: Globenewswire | Image: Eton Pharma
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