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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 21976/S-36
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` NDA 202895/S-13
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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 Product, L.P.
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` Attention: Karen Gerry, B.Sc.
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` Manager, Global Regulatory Affairs
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` 1125 Trenton-Harbourton Road
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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 March 14, 2014,
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`received March 14, 2014, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Prezista® (darunavir) tablet, 75 mg, 150 mg, 600 mg,
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`800 mg and Prezista® (darunavir) oral suspension, 100 mg/mL.
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`We acknowledge receipt of your amendments dated March 27, 2014, April 23, 2014, September
`4, 2014, September 24, 2014, February 23, 2015, March 17, 2015, March 23, 2015, March 31,
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`2015, and April 6, 2015.
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`These Prior Approval supplemental new drug applications propose the following changes:
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`1. To update the CONTRAINDICATIONS section of labeling and, if applicable, the Patient
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`Information (Who should not take Prezista section) with information regarding the
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`following newly added medications: colchicine, dronedarone, and ranolazine and to
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`modify the information for pimozide.
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`2. To update the DRUG INTERACTIONS, Potential for PREZISTA/ritonavir to Affect
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`Other Drugs and Potential for Other Drugs to Affect Darunavir sections, and the
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`CLINICAL PHARMACOLOGY, Pharmacokinetics, Drug Interactions subsection with
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`P-gp information.
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`3. To update DRUG INTERACTIONS, Table 11, Established and
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`Other Potentially Significant Drug Interactions subsection of the labeling and, if
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`applicable, the Patient Information (What should I tell my doctor before I take Prezista?
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`section) with newly added medications or to modify information for existing medications
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`in the following classes:
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`Reference ID: 3766215
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` Drug Class
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` Antiarrhythmics
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` Antibacterial
` Anticoagulant
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` Antidepressant
` Antifungals
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` Antigout
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` Antimycobacterial
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` Antineoplastics
` Antipsychotics/Neuroleptics
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` β-Blockers
` Calcium Channel Blockers
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` Corticosteroid
` Hepatitis C Virus (HCV) Direct-Acting Agents: NS3-4A
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` protease inhibitors
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` HMG-CoA Reductase Inhibitors
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` Immunosupressants
` Narcotic Analgesic/Treatment of Opiod Dependance
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` PDE-5 inhibitors
` Sedative/Hypnotics
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` NDA 21976/S-36
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` NDA 202895/S-13
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` Page 2
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` 4. To update the Drug Interactions, 7.3 Established and Other Potentially Significant Drug
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` Interactions section with information for pitavastatin, acid modifying medications, and
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` HIV integrase strand transfer inhibitors.
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` 5. To update Table 14 (Drug Interactions: Pharmacokinetic Parameters for Darunavir in the
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` Presence of Co-administered Drugs) and Table 15 (Drug Interactions: Pharmacokinetics
` Parameters for Co-administered Drugs in the Presence of Darunavir/Ritonavir) with
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` simeprevir drug-drug interaction information.
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` APPROVAL & LABELING
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`We have completed our review of these supplemental applications, as amended. They are
`approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-
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`upon labeling text.
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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
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`of labeling must be identical to the enclosed labeling (text for the package insert, text for the
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`Reference ID: 3766215
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` NDA 21976/S-36
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` NDA 202895/S-13
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` Page 3
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` patient package insert, Medication Guide), 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
`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
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`“SPL Standard for Content of Labeling Technical Qs and As at
`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 this NDA, including CBE supplements for which FDA has not yet issued an action letter,
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`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
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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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`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
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`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
`Office of Prescription Drug Promotion (OPDP)
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`5901-B Ammendale Road
`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/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
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`Information and Instructions for completing the form can be found at
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
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`more information about submission of promotional materials to the Office of Prescription Drug
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`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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`Reference ID: 3766215
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` NDA 21976/S-36
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` NDA 202895/S-13
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` Page 4
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` All promotional materials that include representations about your drug product must be promptly
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` revised to be consistent with the labeling changes approved in this supplement, including any
` new safety information [21 CFR 314.70(a)(4)]. The revisions in your promotional materials
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` should include prominent disclosure of the important new safety information that appears in the
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` revised package labeling. Within 7 days of receipt of this letter, submit your statement of intent
` to comply with 21 CFR 314.70(a)(4) to the address above or by fax to 301-847-8444.
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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, MPH, Senior Regulatory Project Manager, at
` (301) 796-0759 or the Division mainline at (301) 796-1500.
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` Sincerely,
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` {See appended electronic signature page}
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` Debra Birnkrant, MD
` 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 Research
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` ENCLOSURE(S):
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` Content of Labeling
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`Reference ID: 3766215
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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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`POONAM MISHRA
`05/27/2015
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`Reference ID: 3766215
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