Search Results for 'REMS'

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Product: Qnexa
Company: Vivus
Petition Filer: Joseph Dedvukaj, a Consumer advocate law firm
Petition Number(s): 2012P-0738
Date of Petition: July 12, 2012
Responding Petitions:

Issue and Implication: Whether the available information regarding the safe use of this NDA product is sufficient to reject the pending NDA application.

Action Requested by Petitioner: The Petitioner requests that FDA reject the NDA application of this product or issue a CRL. (Petitioner never mentions exactly what a CRL is.)

Summary of Petition(s): Petitioner notes that this product is a pending application with FDA. It is for obesity. Thus far, from the released data, it appears that there are several safety and adverse event issues with it including teretogenic potential, cardiac events, and pregnancy risk. The bottom line for petitioner is that there is not a lot of data on this product, but what little there is, it does not look favorable for its safety profile. Petitioner asks for a rejection of the application or at least the CRL or other safety precautions such as a Risk Evaluation and Mitigation Strategy (REMS) program or warning labels.

FDA Action: On July 17, 2012, Petitioner withdrew this petition in favor of the one below.

Citizen Petition
Petition Withdrawal

Product: Qnexa®
Company: Vivus
Petition Filer: Joseph Dedvukaj, a Consumer advocate law firm
Petition Number(s): 2012P-0764
Date of Petition: July 17, 2012
Responding Petitions:

Issue and Implication: Whether the available information regarding the safe use of this NDA product is sufficient to reject the pending NDA application.

Action Requested by Petitioner: The Petitioner requests that FDA reject the NDA application of this product or issue a CRL. (Petitioner never mentions exactly what a CRL is.)

Summary of Petition(s): Petitioner notes that this product is a pending application with FDA. It is for obesity. Thus far, from the released data, it appears that there are several safety and adverse event issues with it including teretogenic potential, cardiac events, and pregnancy risk. The bottom line for petitioner is that there is not a lot of data on this product, but what little there is, it does not look favorable for its safety profile. Petitioner asks for a rejection of the application or at least the CRL or other safety precautions such as a Risk Evaluation and Mitigation Strategy (REMS) program or warning labels.

FDA Action: On December 14, 2012, FDA denied this petition. FDA refers to the product as Qsymia(phentermine and topiramate)

Citizen Petition
FDA Action

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