`
`NDA 209606/S-005
`
`APPROVAL LETTER
`
`
`
`Celgene Corporation
`Attention: Qing Wu
`Manager, Regulatory Affairs
`86 Morris Ave.
`Summit, NJ 07901
`
`
`
`Dear Mr. Wu:
`
`
`Please refer to your Supplemental New Drug Application (sNDA) dated and received
`February 2, 2021, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for IDHIFA (enasidenib) tablets.
`
`
`This “Changes Being Effected” supplemental new drug application provides for
`changes to the concentration of the sensitivity solution used in the HPLC-MS method for
` the drug substance.
`
`
`
`APPROVAL
`
`
`We have completed our review of this supplemental application. This supplement is
`approved.
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`set forth under 21 CFR 314.80 and 314.81.
`
`If you have any questions, call Chelsea Bostic, Regulatory Business Process Manager,
`at (301) 796 - 8862.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Ramesh Raghavachari, PhD.
`Branch Chief, B1
`Division of Post-Marketing Activities I
`Office of Lifecycle Drug Products
`Office of Pharmaceutical Quality
`Center for Drug Evaluation and Research
`
`U.S. Food & Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`(b) (4)
`
`
`
`Ramesh
`Raghavachari
`
`Digitally signed by Ramesh Raghavachari
`Date: 7/26/2021 09:57:41PM
`GUID: 502d0913000029f375128b0de8c50020
`
`(
`
`
`
`
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