NDA 022501/S-015
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`SUPPLEMENT APPROVAL
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`
`Allergan Sales, LLC.
`Attention: Carl Louison, MPH
`Senior Manager, Regulatory Affairs
`5 Giralda Farms
`Madison, NJ 07940
`
`
`Dear Mr. Louison:
`
`Please refer to your supplemental new drug application (sNDA) dated and received
`December 16, 2021, and your amendment, submitted under section 505(b) of the
`Federal Food, Drug, and Cosmetic Act (FDCA) for Lo Loestrin Fe (norethindrone
`acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate
`tablets)
`
`We also refer to our Safety Labeling Change (SLC) letter dated November 18, 2021,
`notifying you, under Section 505(o)(4) of the FDCA, of new safety information that we
`believe should be included in the labeling for combined hormonal contraceptive (CHC)
`products. This information pertains to the risk of breast cancer, particularly with
`increased duration of use.
`
`This supplemental new drug application provides for revisions to the labeling for
`Lo Loestrin Fe, consistent with our November 18, 2021, SLC letter.
`
`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.
`
`
`
`
`
`Reference ID: 4976225
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`

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`NDA 022501/S-015
`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
`the FDA automated drug registration and listing system (eLIST), as described at
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
`Prescribing Information, and Patient Package Insert), 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).
`
`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.
`
`
`
`
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`1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`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: 4976225
`
`

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`NDA 022501/S-015
`Page 3
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and
`promotional labeling. For information about submitting promotional materials, see the
`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
`Electronic Format-Promotional Labeling and Advertising Materials for Human
`Prescription Drugs.3
`
`You must submit final promotional materials and Prescribing Information, accompanied
`by a Form FDA 2253, at the time of initial dissemination or publication
`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
`Instructions for completing the form can be found at FDA.gov.5
`
`All promotional materials that include representations about your drug product must be
`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
`in your promotional materials should include prominent disclosure of the important new
`safety information that appears in the revised labeling. Within 7 days of receipt of this
`letter, submit your statement of intent to comply with 21 CFR 314.70(a)(4).
`
`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 Meredith Hillig, MS, Safety Regulatory Project Manager,
`at (301) 796-1218.
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`Catherine Sewell, M.D., M.P.H.
`Deputy Director for Safety
`Division of Urology, Obstetrics, and Gynecology
`Office of Rare Diseases, Pediatrics,
`Urologic, and Reproductive Products
`Center for Drug Evaluation and Research
`
`
`ENCLOSURES:
`• Content of Labeling
`
`
`3 For the most recent version of a guidance, check the FDA guidance web page at
`https://www.fda.gov/media/128163/download.
`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4976225
`
`

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`NDA 022501/S-015
`Page 4
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`o Prescribing Information
`o Patient Package Insert
`
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4976225
`
`

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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.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`CATHERINE A SEWELL
`04/29/2022 10:12:41 AM
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`Reference ID: 4976225
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