NDA 205103-S07
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`SUPPLEMENT APPROVAL
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` Genus Lifesciences Inc.
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` Attn: William Reightler
` Vice President of Regulatory Affairs
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` 514 North 12th Street
` Allentown, PA 18102
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` Dear Mr. Reightler:
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` Please refer to your supplemental new drug application (sNDA) dated received
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` November 12, 2020, submitted under section 505(b) of the Federal Food, Drug, and
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` Cosmetic Act (FDCA) for YOSPRALA (aspirin and omeprazole) delayed-release tablets,
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` 81 mg delayed-release aspirin and 40 mg immediate-release omeprazole; and 325 mg
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` delayed-release aspirin and 40 mg immediate-release omeprazole.
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` We also refer to our letter dated October 15, 2020, notifying you, under Section
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` 505(o)(4) of the FDCA, of new safety information that we believe should be included in
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` the labeling for nonsteroidal anti-inflammatory drug (NSAID) products. This information
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` pertains to the serious risks of fetal renal dysfunction, oligohydramnios, and neonatal
` renal impairment, and Drug Reaction with Eosinophillia and Systemic Symptoms
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` (DRESS).
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` This supplemental new drug application provides for revisions to the labeling for
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` YOSPRALA, consistent with our October 15, 2020 letter.
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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
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` this letter, for use as recommended in the enclosed agreed-upon labeling.
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` You are responsible for assuring that the wording in this FPL is identical to that of the
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` approved content of labeling in the structured product labeling (SPL) format.
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`Reference ID: 4786757
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` NDA 205103-S07
` Page 2
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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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` 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 (Prescribing
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` Information, and Medication Guide), with the addition of any labeling changes in
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` 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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` 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
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` 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
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`format, that includes the changes approved in this supplemental application, as well as
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` 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
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` Word version. The marked-up copy should provide appropriate annotations, including
`supplement number(s) and annual report date(s).
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` All promotional materials that include representations about your drug product must be
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` promptly revised to be consistent with the labeling changes approved in this
` supplement, including any new safety information [21 CFR 314.70(a)(4)]. The revisions
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` in your promotional materials should include prominent disclosure of the important new
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` safety information that appears in the revised labeling. Within 7 days of receipt of this
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` letter, submit your statement of intent to comply with 21 CFR 314.70(a)(4).
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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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` 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: 4786757
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` NDA 205103-S07
` Page 3
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` If you have any questions, call Jacqueline LeeHoffman, PharmD, Safety Regulatory
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` Project Manager, at 240-402-8689.
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` Sincerely,
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` {See appended electronic signature page}
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`Joyce Korvick, M.D., M.P.H.
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`Deputy Director for Safety
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`Division of Gastroenterology (DG)
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`Office of Immunology and Inflammation (OII)
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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: 4786757
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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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`JOYCE A KORVICK
`04/28/2021 09:43:13 AM
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`Reference ID: 4786757
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