(~Ji Ii U.S. FOOD & DRUG
`
`AD M IN I STRATIO N
`
`• ,~~\.-
`
`NDA 021572/S-065
`
`NDA 021572/S-066
`
`
`
`SUPPLEMENT APPROVALS
`
`
`Cubist Pharmaceuticals, LLC
`c/o Merck Sharp and Dohme, Inc.
`
`Attention: Sandra L. Wood, PhD
`Director, Global Regulatory Affairs
`351 North Sumneytown Pike
`Mailstop UG-2CD48
`
`North Wales, PA 19454-2505
`
`
`Dear Dr. Wood:
`
`Please refer to your supplemental new drug applications (sNDAs) dated March 15,
`2021, received March 15, 2021, and your amendments, submitted under section 505(b)
`of the Federal Food, Drug, and Cosmetic Act (FDCA) for the following:
`
`
` NDA 021572/S-065 CUBICIN (daptomycin for injection)
`
` NDA 021572/S-066 CUBICIN RF (daptomycin for injection)
`
`
`
`These “Changes Being Effected” sNDAs provide for revisions to the prescribing
`information (PI), ADVERSE REACTIONS (6) section, Postmarketing Experience (6.2)
`
`subsection, to add information on toxic epidermal necrolysis (TEN). Additionally, the
`WARNINGS AND PRECAUTIONS (5) section has been revised to provide additional
`clarity on the development of drug-resistant bacteria, and the PATIENT COUNSELING
`
`INFORMATION (17) section has been revised to align it with the ADVERSE
`REACTIONS (6) section. Minor editorial revisions have been made throughout the PI.
`
`APPROVAL & LABELING
`
`We have completed our review of these applications, as amended, and they are
`approved, effective on the date of this letter, for use as recommended in the enclosed
`agreed-upon labeling.
`
`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
`FDA.gov.1
`
`
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`
`
`
`
`Reference ID: 4878697
`
`

`

`NDA 021572/S-065
`NDA 021572/S-066
`Page 2
`
`
`Content of labeling must be identical to the enclosed labeling (text for the Prescribing
`Information, Patient Package Insert, Instructions for Use, and Medication Guide), with
`the addition of any labeling changes in pending “Changes Being Effected” (CBE)
`supplements, as well as annual reportable changes not included in the enclosed
`
`labeling.
`
`Information on submitting SPL files using eList may be found in the guidance for
`industry SPL Standard for Content of Labeling Technical Qs and As.2
`
`
`The SPL will be accessible from publicly available labeling repositories.
`
`Also, within 14 days, amend all pending supplemental applications that include labeling
`changes 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 Microsoft Word
`format, that includes the changes approved in this supplemental application, as well as
`annual reportable changes. To facilitate review of your submission(s), 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).
`
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`
`If you have any questions, call J. Christopher Davi, MS, Senior Regulatory Project
`Manager, at (301) 796-0702.
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`Dmitri Iarikov, MD, PhD
`Deputy Director
`Division of Anti-Infectives
`Office of Infectious Diseases
`Center for Drug Evaluation and Research
`
`
`
`ENCLOSURE: Prescribing Information
`
`
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4878697
`
`

`

`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
`10/26/2021 02:29:25 PM
`
`Reference ID: 4878697
`
`(
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