`{
`\-...,,4-
`
`U.S. FOOD & DRUG
`ADMINISTRATION
`
`
`NDA 208700/S-020
`
`
`
`
`
`Reference ID: 4994388
`
`SUPPLEMENT APPROVAL
`
`
`
`
` Advanced Accelerator Applications USA, Inc.
`
`
` Attention: Jouliana Jean Paul, J.D.
` Global Program Regulatory Director
`
`
` 57 E. Willow Street
`
`Millburn, NJ 07041
`
`
`
`
`Dear Ms. Paul:
`
`
`Please refer to your supplemental new drug application (sNDA) dated and received
`
`December 17, 2021, and your amendments, submitted under section 505(b) of the
`
`
`Federal Food, Drug, and Cosmetic Act (FDCA) for LUTATHERA (lutetium Lu 177
`
`dotatate) injection.
`
`
`
`
`This Prior Approval sNDA provides for updates to the carton and container labeling,
`
`
`including the addition of a 2D matrix code for product traceability, increase in vial/lead
`
`shielding label sizes, and editorial changes.
`
`
`APPROVAL & LABELING
`
`
`We have completed our review of this application, as amended. It is approved, effective
`
`
`
`on the date of this letter, for use as recommended in the enclosed agreed-upon
`
`labeling.
`
`
`CARTON AND CONTAINER LABELING
`
`We acknowledge your December 17, 2021, submission containing final printed carton
`
`and container labeling.
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
`
`
`new active ingredients (which includes new salts and new fixed combinations), new
`
`indications, new dosage forms, new dosing regimens, or new routes of administration
`
`
`
`are required to contain an assessment of the safety and effectiveness of the product for
`
`the claimed indication in pediatric patients unless this requirement is waived, deferred,
`
`or inapplicable.
`
`
`Because none of these criteria apply to your application, you are exempt from this
`
`requirement.
`
`
`
`
`
`
`
` NDA 208700/S-020
`
` Page 2
`
`
`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 Emily Pak, Regulatory Health Project Manager, at 301-
`
`837-7531.
`
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`Martha Donoghue, M.D.
`
`Deputy Director
`
`Division of Oncology 2
`
`Office of Oncologic Diseases
`
`
`Center for Drug Evaluation and Research
`
`
`
`
`ENCLOSURE(S):
`
`
`• Carton and Container Labeling
`
`U.S. Food and Drug Administration
`
`
`
`Silver Spring, MD 20993
`
`
`
`www.fda.gov
`
`
`Reference ID: 4994388
`
`
`
`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/
`------------------------------------------------------------
`
`MARTHA B DONOGHUE
`06/06/2022 07:28:31 AM
`
`Reference ID: 4994388
`
`(
`
`
`
`
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