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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 202895
`NDA 21976/S-020
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`Food and Drug Administration
`Silver Spring MD 20993
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`NDA APPROVAL
`NDA SUPPLEMENT APPROVAL
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`Tibotec, Inc
`Attention: Charles Zezza, Ph.D., M.B.A.
`Director, Global Regulatory Affairs
`920 Route US Highway 202S
`PO Box 300
`Raritan, NJ 08869
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`Dear Dr. Zezza:
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`Please refer to your New Drug Application (NDA) dated March 29, 2011 received March 30,
`2011 and your supplemental NDA dated and received June 28, 2011 submitted under section
`505(b) of the Federal Food, Drug, and Cosmetic Act for Prezista® (darunavir) suspension, 100
`mg/mL and tablets, 75 mg, 150 mg, 400 mg, and 600 mg.
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`We acknowledge receipt of your amendments dated:
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`March 29, 2011
`April 13, 2011
`April 19, 2011
`April 26, 2011
`April 28, 2011
`May 3, 2011
`May 9, 2011
`June 2, 2011
`June 7, 2011
`June 9, 2011
`June 10, 2011
`June 15, 201
`June 23, 2011
`June 28, 2011
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`The NDA provides for the use of Prezista® (darunavir) oral suspension in combination with
`other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 3
`years of age and older and weighing at least 10 kg.
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`June 30, 2011
`July 7, 2011
`July 13, 2011
`July 19, 2011
`July 28, 2011
`July 29, 2011
`August 4, 2011
`August 10, 2011
`August 12, 2011
`August 18, 2011
`August 19, 2011
`August 22, 2011
`September 1, 2011
`September 8, 2011
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`September 9, 2011
`September 12, 2011
`September 14, 2011
`September 21, 2011
`September 22, 2011
`September 23, 2011
`September 28, 2011
`November 9, 2011
`November 30, 2011
`December 12, 2011
`December 15, 2011
`December 16, 2011
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`Reference ID: 3060124
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`

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`NDA 202895
` NDA 21976/S-20
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`Page 2
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`The supplemental NDA updates the Prezista® (darunavir) oral tablets labeling within information
`related to the oral suspension formulation.
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`We have completed our review of these applications, as amended. They are approved, effective
`on the date of this letter, for use as recommended in the enclosed agreed-upon labeling text.
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`We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of Highlights of
`prescribing information. This waiver applies to all future supplements containing revised
`labeling unless we notify you otherwise.
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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
`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 and patient
`package insert. Information on submitting SPL files using eLIST may be found in the guidance
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`for industry titled “SPL Standard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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`The SPL will be accessible via publicly available labeling repositories.
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`Also within 14 days, amend all pending supplemental applications 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).
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`CARTON AND IMMEDIATE CONTAINER LABELS
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`For NDA 202895, submit final printed carton and container labels that are identical to the
`enclosed carton and immediate container labels as soon as they are available, but no more than
`30 days after they are printed. Please submit these labels electronically according to the
`guidance for industry titled “Providing Regulatory Submissions in Electronic Format – Human
`Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
`(June 2008).” Alternatively, you may submit 12 paper copies, with 6 of the copies individually
`mounted on heavy-weight paper or similar material. For administrative purposes, designate this
`submission “Final Printed Carton and Container Labels for approved NDA 202895.”
`Approval of this submission by FDA is not required before the labeling is used.
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`Reference ID: 3060124
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`

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`NDA 202895
` NDA 21976/S-20
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`Page 3
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`Marketing the product(s) with FPL that is not identical to the approved labeling text may render
`the product misbranded and an unapproved new drug.
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` MARKET PACKAGE
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`Please submit one market package of the drug product when it is available.
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`If sending via USPS, please send to:
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`If sending via any carrier other than USPS
`(e.g., UPS, DHL), please send to:
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`Linda C. Onaga, MPH
`Food and Drug Administration
`Center for Drug Evaluation and
`Research
`White Oak Building 22, Room: 6321
`10903 New Hampshire Avenue
`Silver Spring, Maryland 20993
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`Linda C. Onaga, MPH
`Food and Drug Administration
`Center for Drug Evaluation and
`Research
`White Oak Building 22, Room: 6321
`10903 New Hampshire Avenue
`Silver Spring, Maryland 20903
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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
`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
`administration are required to contain an assessment of the safety and effectiveness of the
`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
`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
`as a result of drug-brain accumulation.
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`This product is appropriately labeled for use in ages 6 to 17 years for this indication. Therefore,
`no additional studies are needed in this pediatric group.
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`We note that you have fulfilled the pediatric study requirement for ages 3 to 6 years for this
`application.
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`POSTMARKETING COMMITMENTS NOT SUBJECT TO THE REPORTING
`REQUIREMENTS UNDER SECTION 506B
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`We remind you of your postmarketing commitment for NDA 202895:
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`Reference ID: 3060124
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`

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`Study Completion:
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`Final Report Submission:
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`12/2012
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`03/2013
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`Submit chemistry, manufacturing, and controls protocols and all study final reports to this NDA.
`In addition, under 21 CFR 314.81(b)(2)(vii) and 314.81(b)(2)(viii) you should include a status
`summary of each commitment in your annual report to this NDA. The status summary should
`include expected summary completion and final report submission dates, any changes in plans
`since the last annual report, and, for clinical studies/trials, number of patients entered into each
`study/trial. All submissions, including supplements, relating to these postmarketing
`commitments should be prominently labeled “Postmarketing Commitment Protocol,”
`“Postmarketing Commitment Final Report,” or “Postmarketing Commitment
`Correspondence.”
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the
`proposed materials in draft or mock-up form with annotated references, and the package insert
`to:
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`NDA 202895
` NDA 21976/S-20
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`Page 4
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`1816-1
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`Collect dissolution profile data from all full-scale batches manufactured during the first
`year after approval date. The collection of the dissolution data will target the dissolution
`specifications recommended by the FDA and will include dissolution testing at Stage 1,
`2, or 3 as appropriate. Submit the final dissolution report with complete dissolution
`information/data, a proposal for final dissolution specifications, and data analysis with
`the number/percentage of batches tested at Stage 1, 2, or 3 or which failed the dissolution
`specifications recommended by FDA.
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`The timetable you submitted on September 9, 2011 states that you will conduct this study
`according to the following schedule:
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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Drug Marketing, Advertising, and Communications
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
`package insert, at the time of initial dissemination or publication, accompanied by a Form FDA
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`2253. For instruction on completing the Form FDA 2253, see page 2 of the Form. For more
`information about submission of promotional materials to the Division of Drug Marketing,
`Advertising, and Communications (DDMAC), see
`http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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`Reference ID: 3060124
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`Sincerely,
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` {See appended electronic signature page}
`
`Debra Birnkrant, M.D.
`Director
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`Division of Antiviral Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
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`NDA 202895
` NDA 21976/S-20
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`Page 5
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` REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Linda C. Onaga, MPH, Regulatory Project Manager, at (301)
`796-0759.
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`ENCLOSURE(S):
`Content of Labeling
`Carton and Container Label
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`Reference ID: 3060124
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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
`12/16/2011
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`Reference ID: 3060124
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