`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`RESEARCH
`
`
`
`
`
`APPLICATION NUMBER:
`
`22-024
`
`APPLICA TION NUMBER:
`
`REMS
`
`REMS
`
`
`
`
`
`22-024
`
`
`
`NDA 22-024___ ACTOPLUS MET XR (pioglitazone hydrochloride and metformin
`
`hydrochloride extended-release) tablets
`Takeda Global Research and Development Center, Inc.
`
`One Takeda Parkway, Deerfield, IL 60015-2235
`
`
`PROPOSED RISK EVALUATION AND MITIGATION STRATEGY (REMS)
`
`
`I. GOAL:
`
`
`
`The goal of this REMS is to communicate the risks of ACTOPLUS MET XR.
`
`
`
`
`II. REMS ELEMENTS:
`
`
`A. Medication Guide
`
`A Medication Guide will be dispensed with each ACTOPLUS MET XR prescription. The
`
`Medication Guide will be included at the end of the prescribing information as a perforated
`attachment. Each packaging configuration including bottles, sample cards and trays will contain a
`Medication Guide.
`
`Because the Medication Guide is included as part of the packaging and provided by additional
`means for ACTOPLUS MET XR, Takeda has met the requirements of 21 CFR 208.24 for
`
`distribution and dispensing of the Medication Guide.
`
`
`B. Communication Plan
`
`
`The REMS for ACTOPLUS MET XR does not include a Communication Plan.
`
`
`C. Elements To Assure Safe Use
`
`
`
`This REMS for ACTOPLUS MET XR does not include elements to assure safe use.
`
`
`D. Implementation System
`
`
`Because this REMS for ACTOPLUS MET XR does not include elements to assure safe use, an
`
`implementation system is not required.
`
`
`E. Timetable for Submission of Assessments
`
`
`
`The Timetable for Assessments is as follows:
`
`
`
`1st FDAAA assessment: 18 months from approval
`
`2nd FDAAA assessment: 3 years from approval
`
`3rd FDAAA assessment: 7 years from approval
`
`
`
`Takeda will submit the assessments within 60 days of the close of the intervals as noted
`
`above.
`
`
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