`NDA 211192/S-007
`
`
`
`SUPPLEMENT APPROVAL
`
`
`
`
` Agios Pharmaceuticals, Inc.
`
`
` Attention: Charlotte Heyman, MSc
`
` Associate Director, Regulatory Affairs
`
`
` 88 Sidney Street
`
` Cambridge, MA 02139
`
`
`
`Dear Ms. Heyman:
`
`
`Please refer to your supplemental new drug application (sNDA) dated December 22,
`
`
`
`
`2020, received December 22, 2020, submitted under section 505(b) of the Federal
`
`Food, Drug, and Cosmetic Act (FDCA) for TIBSOVO (ivosidenib tablets), for oral use.
`
`This Prior Approval supplemental new drug application provides for the following
`
`changes:
`
`
`
`
`
`• Revised carton labeling to change the country of origin statement from “Made in
`
`
`Portugal” to “Product of Portugal”
`
`
`New carton labeling with country of origin statement “Product of USA” to reflect
`
`
`
` as a site of
`the addition of
`
`manufacture of TIBSOVO
`
`• Revised container labeling to remove the country of origin statement “Made in
`
`Portugal”
`
`
`•
`
`
`APPROVAL & LABELING
`
`
`
`We have completed our review of this application. 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 enclosed
`
`carton and container labeling, 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-007.” Approval of this
`
`submission by FDA is not required before the labeling is used.
`
`
`
`Reference ID: 4764619
`
`(b) (4)
`
`
`
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`R. Angelo de Claro, MD
`
`Division Director
`
`Division of Hematologic Malignancies I
`
`Office of Oncologic Diseases
`
`Center for Drug Evaluation and Research
`
`
`
`
`
` NDA 211192/S-007
`
` Page 2
`
`
`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
`
`
` 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.
`
`
`
`
`
`ENCLOSURE:
`
`• Carton and Container Labeling
`
`
`
`
`
`U.S. Food and Drug Administration
`
`
`
`Silver Spring, MD 20993
`
`
`
`www.fda.gov
`
`
`Reference ID: 4764619
`
`
`
`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
`03/18/2021 03:02:45 PM
`
`Reference ID: 4764619
`
`
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