`RESEARCH
`
`
`
`APPLICATION NUMBER:
`
`202270Orig1s000
`
`RISK ASSESSMENT and RISK
`MITIGATION REVIEW(S)
`
`
`
`
`
`
`
`
`
`
`Risk Evaluation and Mitigation Strategy (REMS) Memorandum
`REMS Retraction
`
`U.S. FOOD AND DRUG ADMINISTRATION
`CENTER FOR DRUG EVALUATION AND RESEARCH
`OFFICE of Drug Evaluation II
`DIVISION of Metabolism and Endocrinology Products
`
`
`________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
`________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
`
`
`NDA/BLA #s:
`Products:
`
`202270
`JANUMET XR (sitagliptin/extended release metformin fixed-dose combination)
`Tablets
`Merck Sharp & Dohme Corporation
`Mary H. Parks, M.D.
`July 1, 2011
`
`
`
`________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
`________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
`
`APPLICANT:
`FROM:
`DATE:
`
`
`On December 3, 2010, we issued a REMS notification letter for the pending NDA for JANUMET XR
`(sitagliptin/extended release metformin fixed-dose combination) to ensure the benefits of the drug
`outweigh the risk of acute pancreatitis, including necrotizing pancreatitis. The REMS was to
`consist of a Medication Guide, and a timetable for submission of assessments of the REMS.
`
`On December 16, 2010, the applicant submitted a proposed REMS which included a Medication
`Guide and a timetable for submission of assessments of the REMS.
`
`On April 14, 2011 we issued Release REMS Requirement letters for NDA 021995/S-017
`JANUVIA (sitagliptin) and NDA 022044/S-016 JANUMET (sitagliptin/metformin
`hydrochloride) after a determination was made that a REMS for these products was no longer
`necessary to ensure the benefits of the drug outweigh the risk described above.
`
`After consultations between the Division of Metabolism and Endocrinology Products (DMEP) in
`the Office of New Drugs (OND) and the Division of Risk Management (DRISK) in the Office of
`Surveillance and Epidemiology (OSE), we have determined that a REMS for JANUMET XR
`(sitagliptin/extended release metformin fixed-dose combination) will not be necessary to ensure the
`benefits of the drug outweigh the risks described above. The Medication Guide will be approved
`as part of the labeling and will be adequate to address the serious and significant public health
`concern and will meet the standard in 21 CFR 208.1. The Medication Guide will be part of the
`approved labeling in accordance with 21 CFR 208. Like other labeling, Medication Guides are
`subject to the safety labeling change provisions of section 505(o)(4) of the FDCA.
`
`
`
`
`
`Reference ID: 2976022
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`AMY G EGAN
`07/20/2011
`Amy Egan for Mary Parks
`
`Reference ID: 2976022
`
`
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