FDA Approves the Merger of the PS-Ambrisentan REMS with the Ambrisentan REMS

FDA Approves the Merger of the PS-Ambrisentan REMS with the Ambrisentan REMS

Today, the Food and Drug Administration (FDA) approved the merger of two separate Risk Evaluation and Mitigation Strategy (REMS) programs into a single, shared system for all ambrisentan products, called the Ambrisentan SS REMS. The PS-Ambrisentan SS REMS, comprised of two abbreviated new drug applications (ANDAs or generics), has merged with the Ambrisentan SS REMS which was formerly comprised of the reference listed drug Letairis, and five ANDAs.

Data migration for stakeholders currently enrolled in the PS-Ambrisentan SS REMS will proceed as follows:

Patients and Prescribers of Ambrisentan:

• Patients who are currently enrolled in the PS-Ambrisentan SS REMS but not in the Ambrisentan SS REMS will be automatically enrolled in the Ambrisentan SS REMS following a data migration. The PS-Ambrisentan SS REMS program will contact patients when their enrollment in the Ambrisentan SS REMS is complete.
• Prescribers who are currently certified in the PS-Ambrisentan SS REMS but not in the Ambrisentan SS REMS will be automatically enrolled in the Ambrisentan SS REMS following a data migration. Prescribers will receive enrollment confirmation and credentials to access the Ambrisentan SS REMS through an automated email upon completion. Prescribers will also receive an automated email when their patient is enrolled in the Ambrisentan SS REMS.

 

Pharmacies that dispense Ambrisentan and Ambrisentan Wholesalers and Distributors:

• Inpatient pharmacies who are currently certified in the PS-Ambrisentan SS REMS but not in the Ambrisentan SS REMS will be automatically certified in the Ambrisentan SS REMS after a data migration. The authorized representative will receive their certification confirmation and credentials to access the Ambrisentan SS REMS through an automated email upon completion.
• Outpatient pharmacies who are currently certified in the PS-Ambrisentan SS REMS but not the Ambrisentan SS REMS will need to enroll to become certified in the Ambrisentan SS REMS. The authorized representatives for the outpatient pharmacies will receive an email from the PS-Ambrisentan SS REMS informing them of the closure of the PS-Ambrisentan SS REMS and the enrollment process for the Ambrisentan SS REMS. The Ambrisentan REMS Coordinating Center will coordinate with outpatient pharmacies to ensure enrollment/certification and registration is completed.
• Wholesalers-distributors who are registered with the PS-Ambrisentan SS REMS but not the Ambrisentan SS REMS will need to register in the Ambrisentan SS REMS program to be able to ship ambrisentan to certified pharmacies. The wholesalers-distributors will receive an email from the PS-Ambrisentan SS REMS informing them of the closure of the PS-Ambrisentan SS REMS and the enrollment process for the Ambrisentan SS REMS. The Ambrisentan REMS Coordinating Center will coordinate with wholesalers-distributors to ensure enrollment/certification and registration is completed.

A REMS is a required risk management plan that uses tools beyond the approved labeling (prescribing information) to manage risks associated with a drug. Under section 505-1 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA has the authority to require a manufacturer to develop a REMS when the agency determines it is necessary to ensure that the benefits of a drug outweigh its risks. REMS programs can be important mechanisms to mitigate serious risks and bring drugs to market that otherwise would not be approvable.

A shared system REMS encompasses multiple prescription drug products and is developed and implemented jointly by two or more applicants. An ANDA referencing a drug with a REMS with Elements to Assure Safe Use (ETASU) is subject to the same ETASU requirements as its reference listed drug. Section 505-1(i)(1)(C) of the FD&C Act states that for any ETASU required for the brand drug, an ANDA may use a single, shared system with the listed drug, or a different, comparable aspect of the ETASU.  A shared system for REMS with ETASU may offer significant benefits to drug applicants and stakeholders in the health care delivery system, generally stemming from opportunities for increased efficiencies for stakeholders and applicants.  FDA therefore strongly encourages ANDA applicants to form a shared system with the listed drug whenever possible. 

For more information on the formation of single, shared system REMS, see the Development of a Shared System REMS Draft Guidance for Industry. 

For more information on the REMS programs for Ambrisentan, please visit the Ambrisentan REMS webpage.