Food and Drug Administration
`
`Silver Spring MD 20993
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`ACCELERATED APPROVAL
`
`
`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 204026
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`
`Celgene Corporation
`Attention: Paul McInulty
`Director, Regulatory Affairs
`400 Connell Drive, Suite 7000
`Berkeley Heights, NJ 07922
`
`Dear Mr. McInulty:
`
`
`
`
`Please refer to your New Drug Application (NDA) dated April 10, 2012, received April 10,
`2012, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
`Pomalyst (pomalidomide) capsules.
`
`
`We acknowledge receipt of your amendments dated April 12; May 11 and 31; July 3, 10, and 20;
`August 3, 7 (2), 13, 24, and 30; September 7 (2), 18, and 19; October 10, 22, and 29; November
`5 and 26; December 4, 7, 14, 17 and 21, 2012; January 4, 7, 10, 14, 22, 24, 28, and 31; February
`4, 6 (2), and 7, 2013.
`
`This new drug application provides for the use of Pomalyst (pomalidomide) capsules in the
`treatment of patients with multiple myeloma who have received at least two prior therapies
`including lenalidomide and bortezomib and have demonstrated disease progression on or within
`60 days of completion of the last therapy.
`
`We have completed our review of this application, as amended. It is approved under the
`provisions of accelerated approval regulations (21 CFR 314.510), effective on the date of this
`letter, for use as recommended in the enclosed agreed-upon labeling text. Marketing of this drug
`product and related activities must adhere to the substance and procedures of the referenced
`accelerated approval regulations.
`
`Reference ID: 3258521
`
`Page 1 of 13
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`CELGENE EXHIBIT 2012
`Coalition for Affordable Drugs VI LLC (Petitioner) v. Celgene Corporation (Patent Owner)
`Case IPR2015-01102
`
`

`
`NDA 204026
`Page 2
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` 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, Medication
`Guide). 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
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
`
`The SPL will be accessible via publicly available labeling repositories.
`
`
`
`CARTON AND IMMEDIATE CONTAINER LABELS
`
`
`Submit final printed carton and container labels that are identical to the carton and immediate
`container labels submitted on January 31, 2013, 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 204026.”
`Approval of this submission by FDA is not required before the labeling is used.
`
`
`
`Marketing the product with FPL that is not identical to the approved labeling text may render the
`product misbranded and an unapproved new drug.
`
`
`ADVISORY COMMITTEE
`
`Your application for Pomalyst (pomalidomide) capsules was not referred to an FDA advisory
`committee because this drug is not the first in its class and the safety profile is similar to that of
`other drugs or biologics approved for this indication.
`
`
`
`ACCELERATED APPROVAL REQUIREMENTS
`
`Products approved under the accelerated approval regulations, 21 CFR 314.510, require further
`adequate and well-controlled studies/clinical trials to verify and describe clinical benefit. You
`are required to conduct such studies/clinical trials with due diligence. If postmarketing
`studies/clinical trials fail to verify clinical benefit or are not conducted with due diligence, we
`may, following an opportunity for a hearing in accordance with 21 CFR 314.530, withdraw this
`
`
`
`Reference ID: 3258521
`
`Page 2 of 13
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`

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`NDA 204026
`Page 3
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`approval. We remind you of your postmarketing requirements specified in your submission
`dated February 6, 2013. These requirements, along with required completion dates, are listed
`below.
`
`PMR 2006-1 Conduct a randomized controlled trial (CC-4047-MM-007) that isolates and
`demonstrates the efficacy and safety of Pomalyst (pomalidomide) in patients with
`previously treated multiple myeloma.
`
`Final Protocol Submission: 12/2012 (completed)
`
`Trial Completion:
`4/2018
`
`
`Final Report Submission: 1/2019
`
`
`PMR 2006-2 Conduct a clinical trial, per FDA guidance [Drug Interaction Studies—Study
`Design, Data Analysis, Implications for Dosing, and Labeling
`Recommendations], to determine the effect of CYP3A induction, which may
`decrease drug exposure, on the PK of Pomalyst (pomalidomide).
`
`
`
`Final Report Submission:
`
`9/2013
`
`Submit final reports to this NDA as a supplemental application. For administrative purposes, all
`submissions relating to these postmarketing requirements must be clearly designated “Subpart
`H Postmarketing Requirement.”
`
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`
`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 indications in pediatric patients unless this requirement is waived,
`deferred, or inapplicable.
`
`
`
`Because this drug product for this indication has an orphan drug designation, you are exempt
`from this requirement.
`
`
`POSTMARKETING REQUIREMENTS UNDER 505(o)
`
`Section 505(o)(3) of the FDCA authorizes FDA to require holders of approved drug and
`biological product applications to conduct postmarketing studies and clinical trials for certain
`purposes, if FDA makes certain findings required by the statute.
`
`We have determined that an analysis of spontaneous postmarketing adverse events reported
`
`under subsection 505(k)(1) of the FDCA will not be sufficient to assess the known serious risk of
`venous thromboembolic events (VTE). Furthermore, the new pharmacovigilance system that
`
`FDA is required to establish under section 505(k)(3) of the FDCA will not be sufficient to assess
`this serious risk.
`
`
`Reference ID: 3258521
`
`Page 3 of 13
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`

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`NDA 204026
`Page 4
`
`Therefore, based on appropriate scientific data, FDA has determined that you are required to
`conduct the following:
`
`
`
`PMR 2006-3 Conduct an observational multi-site inception cohort study of Pomalyst
`(pomalidomide) users to address the questions detailed below:
`
`
`1. To determine the failure rate for each of the different types of initial VTE
`
`prophylaxis for multiple myeloma patients treated with a Pomalyst
`(pomalidomide)-containing regimen.
`
`2. To determine the failure rate for each type of VTE treatment for those patients
`
`with multiple myeloma and a VTE who continue to receive ongoing treatment
`with a Pomalyst (pomalidomide)-containing regimen.
`
`3. To determine the failure rate for each type of post-VTE prophylaxis for those
`
`patients with multiple myeloma and a VTE who continue to receive ongoing
`treatment with a Pomalyst (pomalidomide)-containing regimen.
`
`This observational study will enroll relapsed and refractory multiple myeloma patients
`identified through data sources currently part of the current THAL/REV TEE-01 clinical
`trial; two managed care databases, and a large claims database.
`
`
`
`The timetable you submitted on February 6, 2013, states that you will conduct this study
`according to the following schedule:
`
`
`Final Protocol Submission: 6/2013
`
`Study Completion:
`3/2016
`
`
`Final Report Submission:
`1/2017
`
`
`Finally, we have determined that only clinical trials (rather than nonclinical or observational
`studies) will be sufficient to:
`
`
`Identify an unexpected serious risk of more frequent and/or more severe adverse effects
`of Pomalyst (pomalidomide) due to increased drug exposure resulting from the effects of
`hepatic impairment;
`Identify an unexpected serious risk of more frequent and/or more severe adverse effects
`of Pomalyst (pomalidomide) due to increased drug exposure resulting from the effects of
`renal impairment;
`Identify an unexpected serious risk of more frequent and/or more severe adverse effects
`of Pomalyst (pomalidomide) due to increased drug exposure resulting from the effect of
`
` CYP3A inhibition;
`Identify an unexpected serious risk of more frequent and/or more severe adverse effects
`of Pomalyst (pomalidomide) due to increased drug exposure resulting from the effect of
`food on drug absorption;
`
`
`
`
`
`
`
`
`
`
`
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`Reference ID: 3258521
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`Page 4 of 13
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`

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`NDA 204026
`Page 5
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`
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`Identify an unexpected serious risk of more frequent and/or more severe adverse effects
`of Pomalyst (pomalidomide) when it is used in combination with dexamethasone.
`Identify an unexpected serious risk of QT prolongation with Pomalyst (pomalidomide)
`treatment;
`
`
`
`
`
`
`
`Conduct a clinical trial, per FDA guidance [Pharmacokinetics in Patients with
`Impaired Hepatic Function: Study Design, Data Analysis, and Impact on
`Dosing and Labeling], in patients with baseline hepatic impairment to
`determine the influence of hepatic impairment on the pharmacokinetics (PK)
`and safety of Pomalyst (pomalidomide).
`
`
`Therefore, based on appropriate scientific data, FDA has determined that you are required to
`conduct the following:
`
`PMR 2006-4
`
`
`
`
`
`The timetable you submitted on February 6, 2013, states that you will conduct this trial
`according to the following schedule:
`
`
`Final Protocol Submission: 5/2013
`
`Trial Completion:
`5/2015
`
`
`Final Report Submission:
`2/2016
`
`
`Conduct a clinical trial, per FDA guidance [Pharmacokinetics in Patients with
`Impaired Renal Function--Study Design, Data Analysis, and Impact on
`Dosing and labeling, in patients with baseline renal impairment and those on
`chronic dialysis], to determine the influence of renal impairment on the PK
`
`and safety of Pomalyst (pomalidomide).
`
`
`
`
`
`PMR 2006-5
`
`The timetable you submitted on February 6, 2013, states that you will conduct this trial
`according to the following schedule:
`
`
`Final Protocol Submission: 5/2013
`
`Trial Completion:
`5/2015
`
`
`Final Report Submission:
`2/2016
`
`
` Conduct a clinical trial, per FDA guidance [Drug Interaction Studies—Study
`Design, Data Analysis, Implications for Dosing, and Labeling
`Recommendations], in order to determine the effect of CYP3A inhibition,
`which may increase drug exposure and thereby drug toxicity, on Pomalyst
`(pomalidomide) pharmacokinetics.
`
`The timetable you submitted on February 6, 2013, states that you will conduct this trial
`according to the following schedule:
`
`PMR 2006-6
`
`
`
`Final Protocol Submission:
`Trial Completion:
`
`
`9/2012 (completed)
`
`11/2012 (completed)
`
`
`Reference ID: 3258521
`
`Page 5 of 13
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`

`
`NDA 204026
`Page 6
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`
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`PMR 2006-7
`
`
`
`Final Report Submission:
`
`9/2013
`
`Conduct a food effect clinical trial, per FDA guidance [Food-effect
`Bioavailability and Fed Bioequivalence Studies], in order to determine the
`effect of food on the pharmacokinetics of Pomalyst (pomalidomide). The trial
`should be conducted in patients age > 60 years old using the commercial
`formulation of pomalidomide.
`
`
`The timetable you submitted on February 6, 2013, states that you will conduct this trial
`according to the following schedule:
`
`Final Protocol Submission: 3/2014
`
`Trial Completion:
`12/2014
`
`
`Final Report Submission:
`9/2015
`
`
`
`PMR 2006-8
`
`Conduct a randomized controlled trial (MM-003) of the combination of
`pomalidomide and dexamethasone in patients with previously treated multiple
`myeloma, to determine the safety profile of pomalidomide and dexamethasone
`combination as compared to a treatment arm without pomalidomide.
`
`The timetable you submitted on February 6, 2013, states that you will conduct this trial
`according to the following schedule:
`
`
`
`
`
`Final Protocol Submission: 3/2011 (completed)
`
`Trial Completion:
`
`9/2012 (completed)
`
`Final Report Submission:
`6/2013
`
`
`
`
`
`
`
`PMR 2006-9
`
`Conduct a QT prolongation trial, per FDA guidance [E14 Clinical Evaluation
`of QT/QTc interval Prolongation and Proarrhythmic Potential for Non-
`Antiarrhythmic Drugs], to assess the effect of Pomalyst (pomalidomide) on
`the QT interval.
`
`The timetable you submitted on February 6, 2013, states that you will conduct this trial
`according to the following schedule:
`
`
`Final Protocol Submission: 8/2013
`
`Trial Completion:
`5/2014
`
`
`Final Report Submission:
`2/2015
`
`
`Submit the protocols to your IND 066188, with a cross-reference letter to this NDA. Submit all
`final reports to your NDA. Prominently identify the submission with the following wording in
`bold capital letters at the top of the first page of the submission, as appropriate: “Required
`Postmarketing Protocol Under 505(o)”, “Required Postmarketing Final Report Under
`505(o)”, “Required Postmarketing Correspondence Under 505(o)”.
`
`
`
`Reference ID: 3258521
`
`Page 6 of 13
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`

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`NDA 204026
`Page 7
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`
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`Section 505(o)(3)(E)(ii) of the FDCA requires you to report periodically on the status of any
`study or clinical trial required under this section. This section also requires you to periodically
`report to FDA on the status of any study or clinical trial otherwise undertaken to investigate a
`safety issue. Section 506B of the FDCA, as well as 21 CFR 314.81(b)(2)(vii) requires you to
`report annually on the status of any postmarketing commitments or required studies or clinical
`trials.
`
`FDA will consider the submission of your annual report under section 506B and 21
`CFR 314.81(b)(2)(vii) to satisfy the periodic reporting requirement under section
`505(o)(3)(E)(ii) provided that you include the elements listed in 505(o) and 21 CFR
`314.81(b)(2)(vii). We remind you that to comply with 505(o), your annual report must also
`include a report on the status of any study or clinical trial otherwise undertaken to investigate a
`safety issue. Failure to submit an annual report for studies or clinical trials required under 505(o)
`on the date required will be considered a violation of FDCA section 505(o)(3)(E)(ii) and could
`result in enforcement action.
`
`POSTMARKETING COMMITMENTS SUBJECT TO REPORTING REQUIREMENTS
`
`UNDER SECTION 506B
`
`
`We remind you of your postmarketing commitment:
`
`
`
`PMC 2006-10
`
`
`
`Conduct a clinical trial, per FDA guidance [Drug Interaction Studies—Study
`Design, data Analysis, Implications for Dosing, and Labeling
`Recommendations], in order to determine the effects of a CYP1A2 inducer
`(such as montelukast) on the PK of Pomalyst (pomalidomide). CYP1A2
`induction may decrease Pomalyst (pomalidomide) exposure and result in
`diminished efficacy.
`
`The timetable you submitted on February 6, 2013, states that you will conduct this trial
`according to the following schedule:
`
`Final Protocol Submission: 3/2014
`
`Trial Completion:
`12/2014
`
`
`Final Report Submission:
`9/2015
`
`
`
`
`
`
`
`RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS
`
`
`Section 505-1 of the FDCA authorizes FDA to require the submission of a risk evaluation and
`mitigation strategy (REMS), if FDA determines that such a strategy is necessary to ensure that
`
`the benefits of the drug outweigh the risks [section 505-1(a)].
`
`
`
`
`In accordance with section 505-1 of FDCA, we have determined that a REMS is necessary for
`Pomalyst (pomalidomide) to ensure the benefits of the drug outweigh the risk of teratogenicity.
`
`Reference ID: 3258521
`
`Page 7 of 13
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`

`
`NDA 204026
`Page 8
`
`
`
`Pursuant to 505-1(f)(1), we have determined that Pomalyst (pomalidomide) can be approved
`only if elements necessary to assure safe use are required as part of a REMS to mitigate the risk
`of teratogenicity that is listed in the labeling. The elements to assure safe use will require that
`healthcare professionals who prescribe Pomalyst (pomalidomide) are specially certified, that
`
`pharmacies who dispense Pomalyst (pomalidomide) are specially certified, that Pomalyst
`(pomalidomide) will only be dispensed to patients enrolled in the REMS program with evidence
`or documentation of safe-use conditions, and that female patients or female partners of male
`Pomalyst (pomalidomide) patients who report a pregnancy during treatment with Pomalyst
`(pomalidomide) will be enrolled in a registry. These elements are intended to avoid pregnancy
`occurrence and, should pregnancy occur, monitor and report pregnancy outcomes.
`
`We remind you that section 505-1(f)(8) of FDCA prohibits holders of an approved covered
`application with elements to assure safe use from using any element to block or delay approval
`of an application under section 505(b)(2) or (j). A violation of this provision in 505-1(f) could
`result in enforcement action.
`
`
`Your proposed REMS, submitted on February 6, 2013, and appended to this letter, is approved.
`The REMS consists of elements to assure safe use, an implementation system, and a timetable
`for submission of assessments of the REMS.
`
`Your REMS must be fully operational before you introduce Pomalyst (pomalidomide) into
`interstate commerce.
`
`
`
`The REMS assessment plan should include, but is not limited to, the following:
`
`
`
`1. Pregnancies:
`
`
`
`a. Number of pregnancies reported during the current REMS assessment reporting
`period and during each previous REMS assessment reporting period.
`
`
`
`b. Outcome of each pregnancy
`
`
`
`
`c. Follow-up of outstanding pregnancy reports from previous assessment reporting
`period
`
`
`
`d. Root cause analysis of each reported pregnancy
`
`
`e. Discussion of any new information provided in the most recent Periodic Safety
`Update Report (PSUR) regarding pregnancy. In the electronic REMS assessment
`submission, include a hyperlink to the most recent PSUR that provides information
`on worldwide pregnancies.
`
`
`Reference ID: 3258521
`
`Page 8 of 13
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`

`
`NDA 204026
`Page 9
`
`
`
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`2. Reporting on the restricted distribution program:
`
`
`
`a. Number of pharmacies and physicians certified, and patients enrolled during the
`current REMS assessment reporting period and during each previous REMS
`assessment reporting period
`
`
`
`b. Patient demographics for the current REMS assessment reporting period and for
`previous REMS assessment reporting periods to include gender, age, diagnosis,
`females of reproductive potential (FRP)
`
`
`
` c. Number of female patients for whom pregnancy testing can be discontinued
`
`because menopause has been documented by follicle-stimulating
`hormone/luteinizing hormone (FSH/LH) levels during this REMS assessment
`reporting period and for previous REMS assessment reporting periods
`
`
`
`3. Documentation of safe use conditions
`
`Based on information collected through patient enrollment and mandatory surveys that are
`used to document safe use conditions, provide information on:
`
`
`a. Flagged prescriptions/documentations of safe use of particular interest include
`those that have the potential of allowing pregnant patients access to the drug, and
`those that result in a delay or interruption of treatment. Provide the following,
`relative to flagged prescriptions/documentation of safe use:
`
`
`
`
`i. A list of identified flags, the reasons for the flags, and the actions taken to
`correct. Provide for the reporting period (by month); and summarize
`findings from each previous assessment report.
`
`
`ii. Provide the number and proportion of flagged prescriptions intended for
`an FRP due to lack of documentation of a negative pregnancy test,
`positive pregnancy test, and/or a delay in obtaining a pregnancy test.
`
`
`
`
`
`
`
`
`
`
`iii. Provide the number and proportion of flags that caused a delay in
`treatment initiation or a gap in therapy for patients. Provide the time to
`resolution of flags (mean, minimum, maximum) and include a graph of
`time to resolution versus numbers of prescriptions (or number of
`mandatory surveys conducted to document safe use conditions) for the
`reporting period and for each previous reporting period
`
`
`
`4. The requirements for assessments of an approved REMS under section 505-1(g)(3) include,
`with respect to each goal included in the strategy, an assessment of the extent to which the
`approved strategy, including each element of the strategy, is meeting the goal or whether
`one or more such goals or such elements should be modified.
`
`Reference ID: 3258521
`
`Page 9 of 13
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`

`
`NDA 204026
`Page 10
`
`
`
`We remind you that each REMS assessment report must be submitted with the title of the report
`stating that this is a REMS assessment report, and each report must address all items in the
`REMS assessment plan outlined in this approval letter.
`
`We remind you that in addition to the assessments submitted according to the timetable included
`in the approved REMS, you must submit a REMS assessment and may propose a modification to
`the approved REMS when you submit a supplemental application for a new indication for use as
`described in section 505-1(g)(2)(A) of the FDCA.
`
`If the assessment instruments and methodology for your REMS assessments are not included in
`the REMS supporting document, or if you propose changes to the submitted assessment
`instruments or methodology, you should update the REMS supporting document to include
`specific assessment instrument and methodology information at least 90 days before the
`assessments will be conducted. Updates to the REMS supporting document may be included in a
`new document that references previous REMS supporting document submission(s) for
`unchanged portions. Alternatively, updates may be made by modifying the complete previous
`REMS supporting document, with all changes marked and highlighted. Prominently identify the
`submission containing the assessment instruments and methodology with the following wording
`in bold capital letters at the top of the first page of the submission:
`
`
`NDA 204026 REMS CORRESPONDENCE
`
`UPDATE TO REMS SUPPORTING DOCUMENT - ASSESSMENT
`
`METHODOLOGY)
`
`
`
`An authorized generic drug under this NDA must have an approved REMS prior to marketing.
`
`Should you decide to market, sell, or distribute an authorized generic drug under this NDA,
`contact us to discuss what will be required in the authorized generic drug REMS submission.
`
`Prominently identify the submission containing the REMS assessments or proposed
`modifications with the following wording in bold capital letters at the top of the first page of the
`submission:
`
`
`
`
`
`NDA 204026 REMS ASSESSMENT
`
`NEW SUPPLEMENT FOR NDA204026
`PROPOSED REMS MODIFICATION
`REMS ASSESSMENT
`
`NEW SUPPLEMENT (NEW INDICATION FOR USE)
`
`FOR NDA 204026
`REMS ASSESSMENT
`PROPOSED REMS MODIFICATION (if included)
`
`If you do not submit electronically, please send 5 copies of REMS-related submissions.
`
`Reference ID: 3258521
`
`Page 10 of 13
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`

`
`NDA 204026
`Page 11
`
`
`
`
`
` PROMOTIONAL MATERIALS
`
`Under 21 CFR 314.550, you are required to submit, during the application pre-approval review
`period, all promotional materials, including promotional labeling and advertisements, that you
`intend to use in the first 120 days following marketing approval (i.e., your launch campaign). If
`you have not already met this requirement, you must immediately contact the Office of
`Prescription Drug Promotion (OPDP) at (301) 796-1200. Please ask to speak to a regulatory
`project manager or the appropriate reviewer to discuss this issue.
`
`As further required by 21 CFR 314.550, submit all promotional materials that you intend to use
`after the 120 days following marketing aproval (i.e., your post-launch materials) at least 30 days
`before the intended time of initial dissemination of labeling or initial publication of the
`advertisement. We ask that each submission include a detailed cover letter together with three
`copies each of the promotional materials, annotated references, and approved package insert
`(PI)/Medication Guide/patient PI (as applicable).
`
`Send each submission directly to:
`
`
`OPDP Regulatory Project Manager
`
` Food and Drug Administration
`
` Center for Drug Evaluation and Research
`
` Office of Prescription Drug Promotions (OPDP)
`
` 5901-B Ammendale Road
`
`Beltsville, MD 20705-1266
`
`
`
`
`METHODS VALIDATION
`
`
`
`
`We have not completed validation of the regulatory methods. However, we expect your
`continued cooperation to resolve any problems that may be identified.
`
`REPORTING REQUIREMENTS
`
`
`
`
`We remind you that you must comply with the reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`MEDWATCH-TO-MANUFACTURER PROGRAM
`
`
`The MedWatch-to-Manufacturer Program provides manufacturers with copies of serious adverse
`event reports that are received directly by the FDA. New molecular entities and important new
`biologics qualify for inclusion for three years after approval. Your firm is eligible to receive
`copies of reports for this product. To participate in the program, please see the enrollment
`instructions and program description details at
`
`http://www.fda.gov/Safety/MedWatch/HowToReport/ucm166910.htm.
`
`
`Reference ID: 3258521
`
`Page 11 of 13
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`

`
`NDA 204026
`Page 12
`
`
`
`
`
` POST-ACTION FEEDBACK MEETING
`
`New molecular entities and new biologics qualify for a post-action feedback meeting. Such
`meetings are used to discuss the quality of the application and to evaluate the communication
`process during drug development and marketing application review. The purpose is to learn
`from successful aspects of the review process and to identify areas that could benefit from
`
`improvement. If you would like to have such a meeting with us, call the Regulatory Project
`Manager for this application.
`
`
`
`If you have any questions, call Amy Baird, Regulatory Project Manager, at (301) 796-4969.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Richard Pazdur, M.D.
`Director
`
`Office of Hematology and Oncology Products
`Center for Drug Evaluation and Research
`
`
`
`ENCLOSURE(S):
`Content of Labeling
`Carton and Container Labeling
`REMS
`
`Reference ID: 3258521
`
`Page 12 of 13
`
`

`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`ANN T FARRELL
`02/08/2013
`Farrell, M.D. for Pazdur, M.D.
`
`Reference ID: 3258521
`
`Page 13 of 13