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Postmarket Requirements and Commitments

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FDA/Center for Drug Evaluation and Research
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Update Frequency: Quarterly
Database Last Updated: January 29, 2010
 

7 of 811 Application(s)/Supplement(s)
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Applicant    ABBOTT LABORATORIES
Product    TRILIPIX (FENOFIBRIC ACID)
NDA/BLA Number    22224
NDA/BLA Approval Date   12/15/2008

Annual Report Due Date

(must be submitted within 60 days of this date)

   12/15/2010
Annual Report Received  
Requirement/Commitment Number  1
Required Under  FDAAA Section 505(o)(3)
Description  An observational study to estimate the incidence and risk factors for hospitalized rhabdomyolysis in patients treated with a fibrate in combination with a statin, versus statin or fibrate monotherapy. This study will be conducted using a large, independent database that allows access to medical records to validate diagnoses. A recommended algorithm for identification of the inception cohorts of statin and fibrate users, estimation of person-time on drug, and identification of cases of rhabdomyolysis is provided in "Incidence of Hospitalized Rhabdomyolysis in Patients Treated with Lipid-Lowering Drugs" by Graham and Staffa, published in JAMA December 1, 2004.
Current Status  Ongoing
Requirement/Commitment Number  2
Description  Deferred pediatric clinical trial under PREA for use in combination with a statin to reduce TG and increase HDL-C in pediatric patients ages 12 to 17 years with mixed dyslipidemia who are on optimal statin therapy to achieve their LDL-C goal.
Current Status  Released

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