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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 21660/S-038
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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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` Celgene Corporation
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` Attention: Renu Vaish, M.S.
` Executive Director, Global Regulatory Affairs
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` 400 Connell Drive
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` Suite 7000
` Berkeley Heights, NJ 07922
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`Dear Ms. Vaish:
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`Please refer to your Supplemental New Drug Application (sNDA) dated April 30, 2013, received
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`April 30, 2013, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`(FDCA) for Abraxane® for Injectable Suspension (paclitaxel protein-bound particles for
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`injectable suspension) (albumin-bound)), 100 mg/vial.
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`We also refer to your amendments dated July 1 and September 18, 2013.
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`This “Prior Approval” supplemental new drug application provides for the inclusion of
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`atrioventricular block in Section 6 Adverse Reaction, Post Marketing Experience with Abraxane
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`and other Paclitaxel Formulations, Cardiovascular Subsection.
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`We have completed our review of this supplemental application. It is approved, effective on the
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`date of this letter, for use as recommended in the enclosed, agreed-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 and patient
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`package insert), with the addition of any labeling changes in pending “Changes Being Effected”
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`(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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`Reference ID: 3399014
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` NDA 021660/S-038
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` Page 2
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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,
` 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
`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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`Because none of these criteria apply to your application, you are exempt from this requirement.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
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`labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the
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`proposed materials in draft or mock-up form with annotated references, and the package insert(s)
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`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
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`5901-B Ammendale Road
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`Beltsville, MD 20705-1266
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`As required under 21 CFR 601.12(f)(4), you must submit final promotional materials, and the
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`package insert(s), at the time of initial dissemination or publication, accompanied by a Form
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`FDA 2253. For instruction on completing the Form FDA 2253, see page 2 of the Form. 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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`All promotional materials for your drug product that include representations about your drug
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`product must be promptly revised to make it consistent with the labeling changes approved in
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`this supplement, including any new safety information [21 CFR 601.12(a)(4)]. The revisions to
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`your promotional materials should include prominent disclosure of the important new safety
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`information that appears in the revised package labeling. Within 7 days of receipt of this letter,
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`Reference ID: 3399014
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` NDA 021660/S-038
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` Page 3
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` submit your statement of intent to comply with 21 CFR 601.12(a)(4) to the address above or by
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` 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 Elleni Alebachew, Regulatory Project Manager, at
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`(301) 796-5225.
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`Sincerely,
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`{See appended electronic signature page}
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`Amna Ibrahim, M.D.
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`Deputy Division Director
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`Division of Oncology Products 1
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`Office of Hematology and Oncology 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: 3399014
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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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`AMNA IBRAHIM
`10/30/2013
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`Reference ID: 3399014
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