Search Results for 'REMS'

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Product: Ferriprox®(deferiprone)
Company: ApoPharma and generics
Petition Filer: Cooley’s Anemia Foundation
Petition Number(s): 2020P-0421
Date of Petition: January 27, 2020
Responding Petitions:

Issue and Implication: Whether ANDA products must have the same REMS program of the brand.

Action Requested by Petitioner: The Petitioner is asking FDA to require any ANDA filer to follow the voluntary REMS program the brand has undertaken.

Summary of Petition(s): The Petitioner represents a foundation for a rare blood disorder. This disorder requires patients to undergo lifelong red blood cell transfusions every two weeks. With the transfusions, patients typically get too much iron which needs to be removed. Ferriprox, a drug manufactured by ApoPharma, is the gold standard in treatment. However, the transfusions and Ferriprox therapy has severe and dangerous side effects.

So, ApoPharma has voluntarily undertaken a risk management program (REMS) to monitor the drug use and patient safety. Much of the REMS program is registration of patients and physicians, limited drug distribution, communication, and monitoring of patients. Petitioner claims that there may be several ANDA applicants ready to be approved and asks that they, too, undertake the same or similar REMS program to increase proper medication and patient safety.

FDA Action: On April 29, 2021, FDA denied this petition.

Citizen Petition
FDA Action

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