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` Food and Drug Administration
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` Silver Spring, MD 20993
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` NDA APPROVAL
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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 210660
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`Reference ID: 4420190
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`Exela Pharma Sciences, LLC.
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`Attention: Aruna Koganti, Ph.D, MBA
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`Vice President, Regulatory Affairs and Clinical Programs
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`1245 Blowing Rock Blvd.
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`P.O. Box 818
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`Lenoir, NC 28645
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`Dear Dr. Koganti,
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`Please refer to your New Drug Application (NDA) dated and received July 27, 2018, submitted
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`under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA) for ELCYS™
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`(cysteine hydrochloride injection) USP, 50 mg/mL.
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`We acknowledge receipt of your major amendment dated January 3, 2019, which extended the
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`goal date by three months.
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`This new drug application provides for the use of ELCYS™ (cysteine hydrochloride injection) to
`meet the nutritional requirements of newborn infants requiring total parenteral nutrition (TPN);
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`and of adult and pediatric patients with severe liver disease who may have impaired enzymatic
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`processes and require TPN. It can also be added to amino acid solutions to provide a more
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`complete profile of amino acids for protein synthesis.
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`APPROVAL & LABELING
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`We have completed our review of this application. It is approved, effective on the date of this
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`letter, for use as recommended in the enclosed agreed-upon labeling text.
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`We note that your April 15, 2019, submission includes final printed labeling (FPL) for your
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`Prescribing Information. We have not reviewed this FPL. You are responsible for assuring that
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`the wording in this printed labeling is identical to that of the approved content of labeling in the
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`structured product labeling (SPL) format.
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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 Prescribing Information) as
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` NDA 210660
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`Page 2
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`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
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` Content of Labeling Technical Qs and As, available at
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf
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`The SPL will be accessible via publicly available labeling repositories.
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` CARTON AND CONTAINER LABELING
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`Submit final printed carton and container labeling that are identical to the enclosed carton and
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`container labeling or carton and container labeling submitted on April 3, 2019, as soon as they
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`are available, but no more than 30 days after they are printed. Please submit these labeling
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`electronically according to the guidance for industry titled Providing Regulatory Submissions in
`Electronic Format — Certain Human Pharmaceutical Product Applications and Related
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`Submissions Using the eCTD Specifications (April 2018, Revision 5). For administrative
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`purposes, designate this submission “Final Printed Carton and Container Labeling for approved
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`NDA 210660.” Approval of this submission by FDA is not required before the labeling is used.
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`MARKET PACKAGE
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`Please submit one market package of the drug product when it is available to the following
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`address:
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`Thao M. Vu
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`Food and Drug Administration
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`Center for Drug Evaluation and Research
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`White Oak Building 22, Room: 5232
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`10903 New Hampshire Avenue
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`Silver Spring, Maryland
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`Use zip code 20903 if shipping via United States Postal Service (USPS).
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`Use zip code 20993 if sending via any carrier other than USPS (e.g., UPS, DHL, FedEx).
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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 (which includes new salts and new fixed combinations), new indications, new
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`dosage forms, new dosing regimens, or new routes of administration are required to contain an
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`assessment of the safety and effectiveness of the product for the claimed indication in pediatric
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`patients unless this requirement is waived, 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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`Reference ID: 4420190
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` NDA 210660
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`Page 3
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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 Prescribing
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`Information, Medication Guide, and Patient Package Insert (as applicable) to:
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`OPDP Regulatory Project Manager
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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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`Alternatively, you may submit a request for advisory comments electronically in eCTD format.
`For more information about submitting promotional materials in eCTD format, see the draft
`Guidance for Industry (available at:
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/
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`UCM443702.pdf ).
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`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
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`Prescribing Information, at the time of initial dissemination or publication, accompanied by a
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`Form FDA 2253. Form FDA 2253 is available at
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. 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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`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 Thao Vu, Regulatory Project Manager, at (240) 402-2690.
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`Sincerely,
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`{See appended electronic signature page}
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`Lisa M. Soule, M.D
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`Associate Director
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`Division of Gastroenterology and Inborn Errors
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`Products
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`Office of Drug Evaluation III
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`Center for Drug Evaluation and Research
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`Reference ID: 4420190
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` NDA 210660
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`Page 4
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`ENCLOSURE(S):
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`Content of Labeling: Prescribing Information
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`Carton and Container Labeling
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`Reference ID: 4420190
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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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`LISA M SOULE
`04/16/2019 04:20:19 PM
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`Reference ID: 4420190
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