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` NDA 021660/S-047
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`SUPPLEMENT APPROVAL
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` Abraxis BioScience, LLC
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` c/o Celgene Corporation, a wholly-owned subsidiary of Bristol Meyers Squibb
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` Attention: Martin A. Lessem, JD
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` Senior Director, Global Regulatory Affairs
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` 86 Morris Avenue
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` Summit, NJ 07901
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`Dear Mr. Lessem:
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`Please refer to your supplemental new drug application dated and received
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`March 31, 2020, and your amendments, submitted under section 505(b) of the Federal
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`Food, Drug, and Cosmetic Act (FDCA) for Abraxane (paclitaxel protein bound particles
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`for injectable suspension) (albumin – bound) for 100 mg/vial for injectable suspension.
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`This Prior Approval supplemental new drug application provides for addition of a new
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`adverse reaction, scleroderma to subsection 6.2. In addition, the Package Insert and
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`Patient Package Information were revised to include updates to the following sections
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`for consistency with Food and Drug Administration current labeling policies: Black Box
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`Warning, Dosage and Administration, Dosage Form and Strengths, Contraindications,
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`Warning and Precautions, Adverse Reactions, Drug Interaction, Use in Specific
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`Populations, Overdosage, and Patient Counseling Information.
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`APPROVAL & LABELING
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`We have completed our review of this application, as amended. It is approved, effective
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`on the date of this letter, for use as recommended in the enclosed agreed-upon
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`labeling.
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`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
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`Please note that we have previously granted a waiver of the requirements of 21 CFR
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`201.57(d)(8) regarding the length of Highlights of Prescribing Information.
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`Reference ID: 4661467
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` NDA 021660/S-047
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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
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` content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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` the FDA automated drug registration and listing system (eLIST), as described at
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` FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
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`Prescribing Information and Patient Package Insert), with the addition of any labeling
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`changes in pending “Changes Being Effected” (CBE) supplements, as well as annual
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`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
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`industry SPL Standard for Content of Labeling Technical Qs and As.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 include labeling
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`changes for this new drug application (NDA), including CBE supplements for which FDA
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`has not yet issued an action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in
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`Microsoft Word format, that includes the changes approved in this supplemental
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`application, as well as annual reportable changes. To facilitate review of your
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`submission(s), provide a highlighted or marked-up copy that shows all changes, as well
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`as a clean Microsoft Word version. The marked-up copy should provide appropriate
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`annotations, including supplement number(s) and annual report 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
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`new active ingredients (which includes new salts and new fixed combinations), new
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`indications, new dosage forms, new dosing regimens, or new routes of administration
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`are required to contain an assessment of the safety and effectiveness of the product for
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`the claimed indication in pediatric patients unless this requirement is waived, deferred,
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`or inapplicable.
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`Because none of these criteria apply to your application, you are exempt from this
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`requirement.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and
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`promotional labeling. For information about submitting promotional materials, see the
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`final guidance for industry Providing Regulatory Submissions in Electronic and Non­
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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` 2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
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` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 4661467
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` NDA 021660/S-047
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` Page 3
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` Electronic Format-Promotional Labeling and Advertising Materials for Human
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` Prescription Drugs.3
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`You must submit final promotional materials and Prescribing Information, accompanied
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`by a Form FDA 2253, at the time of initial dissemination or publication
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`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
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`Instructions for completing the form can be found at FDA.gov.5
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`All promotional materials that include representations about your drug product must be
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`promptly revised to be consistent with the labeling changes approved in this
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`supplement, including any new safety information [21 CFR 314.70(a)(4)]. The revisions
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`in your promotional materials should include prominent disclosure of the important new
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`safety information that appears in the revised labeling. Within 7 days of receipt of this
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`letter, submit your statement of intent to comply with 21 CFR 314.70(a)(4).
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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 Sherry Hou, PharmD, Regulatory Project Manager,
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`at 240-402-1813.
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`Sincerely,
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`{See appended electronic signature page}
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`Shanthi Marur, MBBS, MD
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`Associate Director for Safety (acting)
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`Office of Oncologic Diseases
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`Center for Drug Evaluation and Research
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`ENCLOSURES:
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`• Content of Labeling
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`o Prescribing Information
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`o Patient Package Insert
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` 3 For the most recent version of a guidance, check the FDA guidance web page at
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` https://www.fda.gov/media/128163/download.
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` 4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
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` 5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
`www.fda.gov
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`Reference ID: 4661467
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`Signature Page 1 of 1
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`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
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`/s/
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`SHANTHI N MARUR
`08/25/2020 11:00:28 AM
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`Reference ID: 4661467
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`(
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