`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
` NDA 205834/S-010
`
`
`
`
`
`
`
`
` Food and Drug Administration
`
`
`
` Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL
`
`
` Gilead Sciences, Inc.
`
`
`
` Attention: Linda Lintao, RAC
`
` Manager, Regulatory Affairs
`
` 333 Lakeside Drive
` Foster City, CA 94404
`
`
`
`
`
`Dear Ms. Lintao:
`
`
`
`
`
`
`Please refer to your Supplemental New Drug Application (sNDA) dated and received on
`
`
`December 11, 2015 and your amendments submitted under section 505(b) of the Federal Food,
`Drug, and Cosmetic Act (FDCA) for HARVONI® (ledipasvir and sofosbuvir), tablet, 90 mg/400
`
`
`
` mg.
`
` This Prior Approval supplemental new drug application proposes to add information to the
`
`
`
`
`
`
` NONCLINICAL TOXICOLOGY, Carcinogenesis and Mutagenesis, Impairment of Fertility
` section of the labeling from study TX-256-2016, “104-Week Oral Gavage Carcinogenicity Study
`
`
` with GS-5885 in Rats”.
`
`APPROVAL & LABELING
`
`
`
`We have completed our review of this supplemental application, as amended. It is approved,
`
`
`
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`
`text.
`
` CONTENT OF LABELING
`
`
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the content of
`
`
`
`
`
`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
`
`automated drug registration and listing system (eLIST), as described at
`
`
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`
`of labeling must be identical to the enclosed labeling (text for the package insert, text for the
`
`
`
`patient package insert), with the addition of any labeling changes in pending “Changes Being
`
`
`Effected” (CBE) supplements, as well as annual reportable changes not included in the enclosed
`
`labeling.
`
`
`
`
`Information on submitting SPL files using eList may be found in the guidance for industry titled
`
`
`
`“SPL Standard for Content of Labeling Technical Qs and As at
`
`
`
`
`
`Reference ID: 3943002
`
`
`
`
`
`
`
`
`
`
`
`
`
` NDA 205834/S-010
`
` Page 2
`
`
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`
` CM072392.pdf
`
` The SPL will be accessible from publicly available labeling repositories.
`
`
`
`
`Also within 14 days, amend all pending supplemental applications that includes labeling changes
`
`
`for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
`
`
`
`
`with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
`changes approved in this supplemental application, as well as annual reportable changes and
`
` annotate each change. To facilitate review of your submission, provide a highlighted or marked-
` up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
`
` should provide appropriate annotations, including supplement number(s) and annual report
`
`
`
` date(s).
`
` 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 Linda C. Onaga, Senior Regulatory Project Manager, at (301)
`
`796-0759 or the Division mainline (301) 796-1500.
`
`
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`
`Debra Birnkrant, MD
`
`Director
`
`Division of Antiviral Products
`
`Office of Antimicrobial Products
`
`Center for Drug Evaluation and Research
`
`
`
`ENCLOSURE(S):
`
`
`Content of Labeling
`
`Reference ID: 3943002
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`POONAM MISHRA
`06/08/2016
`
`Reference ID: 3943002
`
`(
`
`
`
`