`
`NDA 211192/S-002
`
`Agios Pharmaceuticals, Inc.
`Attention: Jamie Cohen, PhD
`Director, Regulatory Affairs
`88 Sidney Street
`Cambridge, MA 02139
`
`
`Dear Dr. Cohen:
`
`
`Please refer to your supplemental new drug application (sNDA) dated October 7, 2019,
`
`received October 7, 2019, and your amendments, submitted under section 505(b) of the
`
`Federal Food, Drug, and Cosmetic Act (FDCA) for TIBSOVO (ivosidenib tablets), 250
`mg.
`
`This Prior Approval supplemental new drug application provides for carton labeling for
`
`
`TIBSOVO to contain the 60-count bottle of 250 mg ivosidenib tablets (NDC 71334-100
`01).
`
`APPROVAL & LABELING
`
`
`We have completed our review of this application, as amended. It is approved, effective
`on the date of this letter, for use as recommended in the enclosed agreed-upon
`labeling.
`
`CARTON AND CONTAINER LABELING
`
`
`
`Submit final printed carton and container labeling that are identical to the carton and
`container labeling submitted on March 12, 2020, as soon as they are available, but no
`
`more than 30 days after they are printed. Please submit these labeling electronically
`
`according to the guidance for industry Providing Regulatory Submissions in Electronic
`
`
`Format — Certain Human Pharmaceutical Product Applications and Related
`Submissions Using the eCTD Specifications. For administrative purposes, designate
`
`this submission “Final Printed Carton and Container Labeling for approved
`
`NDA 211192/S-002.” Approval of this submission by FDA is not required before the
`
`
`labeling is used.
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
`
`
`new active ingredients (which includes new salts and new fixed combinations), new
`indications, new dosage forms, new dosing regimens, or new routes of administration
`
`Reference ID: 4576308
`
`
`
`NDA 211192/S-002
`Page 2
`
` are required to contain an assessment of the safety and effectiveness of the product for
`
`
`the claimed indication in pediatric patients unless this requirement is waived, deferred,
`or inapplicable.
`
`Because none of these criteria apply to your application, you are exempt from this
`
`
`requirement.
`
`REPORTING REQUIREMENTS
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`
`If you have any questions, call Esther Park, Senior Regulatory Health Project Manager,
`at (301) 796-2811.
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`R. Angelo de Claro, MD
`Acting Division Director
`Division of Hematologic Malignancies I
`Office of Oncologic Diseases
`
`Center for Drug Evaluation and Research
`
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4576308
`
`
`
`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`ROMEO A DE CLARO
`03/17/2020 10:15:33 AM
`
`Reference ID: 4576308
`
`(
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