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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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`NDA 205834/S-11
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`APPROVAL LETTER
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`Gilead Sciences, Inc.
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`Attention: Prachi Shah, MBS, RAC
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`Associate Manager, Regulatory Affairs
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`333 Lakeside Drive
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`Foster City, CA 94404
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`Dear Ms. Shah:
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`Please refer to your Supplemental New Drug Application (sNDA) dated December 11, 2015,
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`received December 11, 2015, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Harvoni® (ledipasvir/sofosbuvir), tablet, 90 mg/400 mg.
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`This Changes Being Effected supplemental new drug application proposes the following change:
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`• To revise the container label to include text “Take 1 tablet once daily”
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`We have completed our review of this supplemental new drug application, as amended. This
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`supplement is approved.
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`We remind you that you must comply with the requirements for an approved NDA set forth
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`under 21 CFR 314.80 and 314.81.
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`If you have any questions, call Mammah Sia Borbor, Regulatory Project Manager, at (301) 796
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`7731 or (301) 796-1500.
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`Sincerely,
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`{See appended electronic signature page}
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`Jeffrey Murray, M.D., M.P.H.
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`Deputy Director
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`Division of Antiviral Products
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`Office of Antimicrobial Products
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`Center for Drug Evaluation and Research
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`Reference ID: 3888477
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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/
`----------------------------------------------------
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`JEFFREY S MURRAY
`02/17/2016
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`Reference ID: 3888477
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`(
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