Tag: Alkindi Sprinkle

Alkindi Sprinkle

Regulatory/FDA

OPDP Enforcement Letter to Eton Pharmaceuticals Cites Omission of Risk Info in Sponsored Links

OPDP Enforcement Letter to Eton Pharmaceuticals Cites Omission of Risk Info in Sponsored Links

Aug. 30, 2021 – In an Aug. 9 Untitled Letter, FDA’s Office of Prescription Drug Promotion (OPDP) cited Eton Pharmaceuticals Inc. for presenting benefit information in sponsored links for Alkindi® Sprinkle (hydrocortisone) oral granules without including any risk information about the product, which “is used in a vulnerable pediatric population” and may cause serious adverse […]

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