CENTER FOR DRUG EVALUATION AND
`RESEARCH
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`APPLICATION NUMBER:
`022501Orig1s000
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`APPROVAL LETTER
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`Food and Drug Administration
`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 022501
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`Warner Chilcott Company, LLC
`Attention: Ileana Brown
`Director, Regulatory Affairs
`100 Enterprise Drive
`Rockaway, NJ 07866
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`Dear Ms. Brown:
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`Please refer to your New Drug Application (NDA) dated and received March 26, 2009,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Lo Loestrin Fe
`(norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets, and ferrous fumarate
`tablets).
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`We acknowledge receipt of your amendments dated April 20, May 6, 2010, and
`October 19, 2010 (2).
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`The April 20, 2010, submission constituted a complete response to our January 26, 2010, action
`letter.
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`This new drug application provides for the use of Lo Loestrin Fe (norethindrone acetate and
`ethinyl estradiol tablets, ethinyl estradiol tablets, and ferrous fumarate tablets) by women
`to prevent pregnancy.
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`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 text.
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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, via the FDA
`automated drug registration and listing system (eLIST), the content of labeling
`[21 CFR 314.50(l)] in structured product labeling (SPL) format, as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm, that is
`identical to the enclosed labeling (text for the package insert, text for patient labeling).
`Information on submitting SPL files using eLIST may be found in the guidance for industry
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`titled “SPL Standard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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`NDA 022501
`Page 2
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`The SPL will be accessible via publicly available labeling repositories.
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`CARTON AND IMMEDIATE CONTAINER LABELS
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`Submit final printed carton and container labels that are identical to the carton and immediate
`container labels submitted on October 19, 2010 (enclosed), as soon as they are available, but no
`more than 30 days after they are printed. Please submit these labels electronically according to
`the guidance for industry titled “Providing Regulatory Submissions in Electronic Format –
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`Human Pharmaceutical Product Applications and Related Submissions Using the eCTD
`Specifications (June 2008).” Alternatively, you may submit 12 paper copies, with 6 of the copies
`individually mounted on heavy-weight paper or similar material. For administrative purposes,
`designate this submission “Final Printed Carton and Container Labels for approved NDA
`022501.” Approval of this submission by FDA is not required before the labeling is used.
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`Marketing the product with FPL that is not identical to the approved labeling text may render the
`product misbranded and an unapproved new drug.
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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
`active ingredients, 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.
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`We are waiving the pediatric study requirement for pre-menarcheal patients because necessary
`studies are impossible or highly impracticable. This is because pre-menarcheal patients are not
`at risk of becoming pregnant and the use of this product before menarche is not indicated. We
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`note that you have fulfilled the pediatric study requirement for post-menarcheal pediatric patients
`by extrapolation of adult data.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the
`proposed materials in draft or mock-up form with annotated references, and the package insert
`to:
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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Drug Marketing, Advertising, and Communications
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`NDA 022501
`Page 3
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`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
`package insert, at the time of initial dissemination or publication, accompanied by a
`Form FDA 2253. For instruction on completing the Form FDA 2253, see page 2 of the Form.
`For more information about submission of promotional materials to the Division of Drug
`Marketing, Advertising, and Communications (DDMAC), 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
`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Pamela Lucarelli, Regulatory Project Manager, at
`(301) 796-3961.
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`Sincerely,
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`{See appended electronic signature page}
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`Scott Monroe, M.D.
`Director
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`Division of Reproductive and Urologic Products
`Office of Drug Evaluation III
`Center for Drug Evaluation and Research
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`ENCLOSURES:
`Content of Labeling
`Carton and Container Labeling
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
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`SCOTT E MONROE
`10/21/2010
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`Reference ID: 2853287
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