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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 21976/S-29
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` NDA 202895/S-6
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`Food and Drug Administration
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` Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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` Janssen Products, L.P.
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` Attention: Karen Gerry, BSc
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` Manager, Global Regulatory Affairs
` 1125 Trenton-Harbourton Rd
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` Titusville, NJ 08560
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`Dear Ms. Gerry:
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`Please refer to your Supplemental New Drug Applications (sNDA) dated and received August 3,
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`2012, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
` Prezista® (darunavir) tablets, 75 mg, 150 mg, 400 mg, 600 600 mg, and 800 mg, and Prezista®
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` (darunavir) oral suspension, 100 mg/mL.
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` We acknowledge receipt of your amendments dated:
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` August 16, 2012
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` August 27, 2012
` September 5, 2012
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` October 5, 2012
` November 2, 2012
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` November 15, 2012
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` November 21, 2012
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`These “Prior Approval” supplemental new drug applications propose to update labeling with
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`once daily dosing in:
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`November 28, 2012
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`December 6, 2012
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`December 17, 2012
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`December 18, 2012
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`January 7, 2013
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`January 24, 2013
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`January 29, 2013.
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` o HIV-1 infected, treatment-naïve pediatric patients 3 to less than 12 years of age, and
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` o HIV-1 infected, treatment-experienced pediatric patients 3 to less than 18 years of age
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`with no darunavir resistance associated substitutions.
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` These changes are based on pharmacokinetic modeling and simulation data that includes the
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` darunavir/ritonavir pediatric clinical trials TMC114-C230, TMC114-C212, and TMC114-228.
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` We have completed our review of these supplemental applications, as amended. They are
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` approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-
`upon labeling text.
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`Reference ID: 3254437
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` NDA 21976/S-29
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` NDA 202895/S-6
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` Page 2
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`CONTENT OF LABELING
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`As soon as possible, but no later than 14 days from the date of this letter, submit the content of
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`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
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`automated drug registration and listing system (eLIST), as described at
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`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
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`patient package insert, Instruction for Use), with the addition of any labeling changes in pending
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`“Changes Being Effected” (CBE) supplements, as well as annual reportable changes not
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`included in the enclosed labeling.
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` 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
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
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` CM072392.pdf
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` The SPL will be accessible from publicly available labeling repositories.
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` Also within 14 days, amend all pending supplemental applications that includes labeling changes
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` for these NDAs, 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
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`changes approved in this supplemental application, as well as annual reportable changes and
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` annotate each change. To facilitate review of your submission, provide a highlighted or marked-
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` up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
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` should provide appropriate annotations, including supplement number(s) and annual report
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` date(s).
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`REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
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`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
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`administration are required to contain an assessment of the safety and effectiveness of the
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`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
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`deferred, or inapplicable.
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`We are waiving the pediatric study requirement for ages 0 to 3 years because there is evidence
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`strongly suggesting that the drug product would be unsafe in this pediatric group. This decision is
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` based on the results of juvenile rat toxicology studies that provide evidence of a potential safety risk
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` as a result of drug-brain accumulation.
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`We note that you have fulfilled the pediatric study requirement for ages 3 to less than 18 years
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`for this application.
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`PROMOTIONAL MATERIALS
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`Reference ID: 3254437
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` NDA 21976/S-29
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` NDA 202895/S-6
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` Page 3
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` You may request advisory comments on proposed introductory advertising and promotional
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` labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
` comments, (2) the proposed materials in draft or mock-up form with annotated references, and
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` (3) the package insert(s) to:
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`Food and Drug Administration
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`Center for Drug Evaluation and Research
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`Office of Prescription Drug Promotion (OPDP)
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`5901-B Ammendale Road
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`Beltsville, MD 20705-1266
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`You must submit final promotional materials and package insert(s), accompanied by a Form
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`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
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`FDA 2253 is available at http://www.fda.gov/opacom/morechoices/fdaforms/cder.html;
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`instructions are provided on page 2 of the form. For more information about submission of
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`promotional materials to the Office of Prescription Drug Promotion (OPDP), see
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`http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Linda C. Onaga, Regulatory Project Manager, at (301) 796-0759
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`or (301) 796-1500.
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`Sincerely,
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`{See appended electronic signature page}
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`Debra Birnkrant, MD
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`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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`ENCLOSURE(S):
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`Content of Labeling
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`Reference ID: 3254437
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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
`02/01/2013
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`Reference ID: 3254437
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