Search Results for 'REMS'

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Product: Zelnorm®(tegaserod) Tablets
Company: Novartis/US WorldMeds LLC
Petition Filer: Hyman Phelps, a law firm
Petition Number(s): 2018P-4490
Date of Petition: November 27, 2018
Responding Petitions:

Issue and Implication: Whether the FDA standards for re-introducing discontinued products from the market is sufficient to ensure safety.

Action Requested by Petitioner: The Petitioner is asking FDA to deny the approval of the Supplemental New Drug Application (sNDA) requesting approval of Zelnorm®(tegaserod).

Summary of Petition(s): Approved in 2002, Zelnorm was introduced onto the market for the treatment of Irritable Bowel Syndrome with the primary symptom of constipation. After a few years, it became apparent that the product had serious adverse events including suicidal ideation and cardiovascular events. Eventually, the product sponsor Novartis removed the drug from the market and made it available for a limited number of patients, restricted to emergencies.

US WorldMeds purchased the NDA and has submitted an sNDA for this product, seeking to re-introduce it to the market with a limited indication for adult women under the age of 65 with low risk of cardiovascular events. The sNDA also requests certain label restrictions and warnings but does not contain any new studies.

Petitioner argues that that FDA should deny this sNDA for essentially one reason. Petitioner argues that it does not meet the legal threshold of approval. In short, there is not substantial evidence, let alone really any evidence, that the product’s benefits outweigh its risks. There are no new studies or any substantial data to justify its re-introduction into the market. Any post-hoc analysis done is insufficient to demonstrate that safety and efficacy are met. The lack of availability of an effective drug with a similar mechanism of action is insufficient to approve the sNDA.

As an alternative, if FDA approves the sNDA, Petitioner asks that FDA severely restrict its usage through an appropriate REMS program.

FDA Action: On March 29, 2019, FDA denied this petition.

Citizen Petition
FDA Action

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