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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`Food and Drug Administration
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`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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` RELEASE REMS REQUIREMENT
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`Takeda Global Research & Development Center, Inc.
`Attention: Jessie Y. Lee, Ph.D., RAC
`Manager, Regulatory Affairs
`One Takeda Parkway
`Deerfield, IL 60015-2235
`
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`Dear Dr. Lee:
`
`Please refer to your New Drug Applications (NDAs) submitted under section 505(b) of the
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`Federal Food, Drug, and Cosmetic Act (FDCA) for:
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`• ACTOS (pioglitazone hydrochloride) Tablets,
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`• ACTOPLUS MET (pioglitazone hydrochloride and metformin hydrochloride) fixed-dose
`combination Tablets,
`• ACTOPLUS MET XR (pioglitazone hydrochloride and metformin hydrochloride extended-
`release) fixed-dose combination Tablets, and
`• DUETACT (pioglitazone hydrochloride and glimepiride) fixed-dose combination Tablets.
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`We acknowledge receipt of your amendments dated April 5 and 6, and May 1 and 9, 2012, and
`your risk evaluation and mitigation strategy (REMS) assessment dated February 1, 2012. After
`consultation between the Office of New Drugs (OND) and the Office of Surveillance and
`Epidemiology (OSE), we have found the REMS assessment to be adequate.
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`These supplemental new drug applications propose to eliminate the requirement for the approved
`REMS for these pioglitazone-containing products.
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`RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS
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`A REMS for ACTOS (pioglitazone hydrochloride) and DUETACT (pioglitazone hydrochloride
`and glimepiride) was originally approved on September 9, 2009; a REMS for ACTOPLUS MET
`(pioglitazone hydrochloride and metformin hydrochloride) was originally approved on
`September 14, 2009; and a REMS for ACTOPLUS MET XR (pioglitazone hydrochloride and
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`NDA 021073/S-045
`NDA 021842/S-016
`NDA 022024/S-009
`NDA 021925/S-012
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`Reference ID: 3132401
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` NDA 021073/S-045; NDA 021842/S-016; NDA 022024/S-009; NDA 21925/S-012
`Page 2
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`metformin hydrochloride extended-release) was originally approved on May 12, 2009. The most
`recent REMS modification for all four pioglitazone-containing products was approved on
`August 4, 2011. The REMS consists of a Medication Guide and a timetable for submission of
`assessments of the REMS.
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`You propose that FDA no longer require a REMS for these pioglitazone-containing products.
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`We have determined that maintaining the Medication Guide as part of the approved labeling is
`adequate to address the serious and significant public health concern and meets the standard in
`21 CFR 208.1. Therefore, it is no longer necessary to include the Medication Guide as an
`element of the approved REMS to ensure that the benefits of these pioglitazone-containing
`products outweigh the risks.
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`Therefore, we agree with your proposal, and a REMS for these pioglitazone-containing products
`is no longer required.
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`We remind you that the Medication Guide will continue to be part of the approved labeling in
`accordance with 21 CFR 208.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`If you have any questions, please contact Jena Weber, Regulatory Project Manager, at
`(301) 796-1306.
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`Reference ID: 3132401
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`Sincerely,
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`{See appended electronic signature page}
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`Amy G. Egan, M.D., M.P.H.
`Deputy Director for Safety
`Division of Metabolism & Endocrinology Products
`Center for Drug Evaluation and Research
`Food and Drug Administration
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`---------------------------------------------------------------------------------------------------------
`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
`05/17/2012
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`Reference ID: 3132401
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`
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