`NDA 21825/S007
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`SUPPLEMENT APPROVAL
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` ApoPharma
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` c/o Cato Research, Ltd.
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` Attention: Sheila Plant, PhD
` Director, Regulatory Strategy
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` 4364 South Alston Avenue
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` Durham, NC 27713-2220
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`Dear Dr. Plant:
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`Please refer to your supplemental new drug application (sNDA) dated and received
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`August 30, 2019, and your amendments, submitted under section 505(b) of the Federal
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`Food, Drug, and Cosmetic Act (FDCA) for Ferriprox (deferiprone), 500 mg and 1,000 mg
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`Tablets.
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`This Prior Approval supplemental new drug application provides for updates to the
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`labeling to comply with the Pregnancy and Lactation Labeling Rule (PLLR).
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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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`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 Medication Guide, with the addition of any labeling changes
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`in pending “Changes Being Effected” (CBE) supplements, as well as annual reportable
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`changes not included in the enclosed labeling.
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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`Reference ID: 4563476
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` NDA 21825/S007
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` Page 2
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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 Charlene Wheeler, Acting Chief, Project Management
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`Staff, at 301-796-1141.
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`Sincerely,
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`{See appended electronic signature page}
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`
`Albert Deisseroth, MD, PhD
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`Associate Director
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`Division of Hematology Products
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`Office of New Drugs
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`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
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`• Content of Labeling
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`o Prescribing Information
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`o Medication Guide
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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: 4563476
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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/
`------------------------------------------------------------
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`ALBERT B DEISSEROTH
`02/20/2020 10:31:28 AM
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`Reference ID: 4563476
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`(
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