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` NDA 21572/S-063
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` NDA 21572/S-064
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`SUPPLEMENT APPROVAL
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`
` Cubist Pharmaceuticals, LLC
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`c/o Merck Sharp and Dohme, Inc
`
`
` Attention: Casey Raudebush, MSN
` Director, Global Regulatory Affairs
`
`
` PO Box 1000, Mailstop UG-2C48
`
`351 North Sumneytown Pike
`
` North Wales, PA 19454-2505
`
`
`
` Dear Ms. Raudenbush:
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`
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` Please refer to your supplemental new drug applications (sNDAs) dated March 6, 2020,
` received March 6, 2020, and your amendments, submitted under section 505(b) of the
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` Federal Food, Drug, and Cosmetic Act (FDCA) for the following:
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`NDA 021572/S-063 CUBICIN (daptomycin for injection)
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`NDA 021572/S-064 CUBICIN RF (daptomycin for injection)
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` These Prior Approval supplemental new drug applications provide for revisions to the
` WARNINGS AND PRECAUTIONS Section (5) of the prescribing information by adding
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` subsections (5.4) Drug Reaction with Eosinophilia and Systemic Symptoms
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` (DRESS) and (5.5) Tubulointerstitial Nephritis (TIN). Drug Reaction with Eosinophilia
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` and Systemic Symptoms (DRESS) and tubulointerstitial nephritis (TIN) are also added
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` to the ADVERSE REACTIONS Section (6), (6.2) Post-Marketing Experience
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`
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` subsection. In addition, minor editorial changes have been made throughout the
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`prescribing information.
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` APPROVAL & LABELING
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` We have completed our review of these applications, as amended. They are approved,
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` effective on the date of this letter, for use as recommended in the enclosed agreed-
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`upon labeling.
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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 labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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`
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`the FDA automated drug registration and listing system (eLIST), as described at
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`Reference ID: 4661886
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` NDA 21572/S-063
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` NDA 21572/S-064
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`Page 2
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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, with the addition of any labeling changes in pending “Changes
` Being Effected” (CBE) supplements, as well as annual reportable changes not included
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`in the enclosed labelings.
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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
` changes for these NDAs, including CBE supplements for which FDA has not yet issued
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`
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` an action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
` format, that includes the changes approved in these supplemental applications, as well
`
` as annual reportable changes. To facilitate review of your submission(s), provide a
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` highlighted or marked-up copy that shows all changes, as well as a clean Microsoft
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` Word version. The marked-up copy should provide appropriate annotations, including
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`supplement number(s) and annual report date(s).
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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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`
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` If you have any questions, call J. Christopher Davi, MS, Senior Regulatory Project
`
`
` Manager, at (301) 796-1203.
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` Sincerely,
`
` {See appended electronic signature page}
`
`
` Dmirti Iarikov, MD, PhD
`
` Deputy Director
` Division of Anti-Infectives
`
`
` Office of Infectious Diseases
` Center for Drug Evaluation and Research
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`
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`
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` ENCLOSURE(S):
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`• Content of Labeling
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`
`o Prescribing Information
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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: 4661886
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`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`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.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`DMITRI IARIKOV
`08/26/2020 05:45:54 AM
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`Reference ID: 4661886
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`