Requests that the FDA determine whether the original formulation submitted for the Reference Listed Drng (RLD), ISTURSIA (osilodrostat) tablets 10 mg (Product Number 003); New Drug Application (NDA) 212801, held by RECORDATI RARE DISEASES INC has been voluntarily withdrawn from the commercial market or withdrawn from sale for reasons of safety or eff | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-4574

Requests that the FDA determine whether the original formulation submitted for the Reference Listed Drng (RLD), ISTURSIA (osilodrostat) tablets 10 mg (Product Number 003); New Drug Application (NDA) 212801, held by RECORDATI RARE DISEASES INC has been voluntarily withdrawn from the commercial market or withdrawn from sale for reasons of safety or eff

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensApr 24, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Acknowledgment Letter from FDA CDER to Annora Pharma Private Limited	Apr 24, 2026	--

Keywords

CDER

Citizen Petition

Annora Pharma Private Limited

determine whether the original

formulation submitted for the

Reference Listed Drng (RLD), ISTURSIA

(osilodrostat) tablets 10 mg

(Product Number 003)

Data from Regulations.gov