`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`Approval Package for:
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`APPLICATION NUMBER:
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`204654Orig1s000
`
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`Lo Minastrin Fe
`
`Trade Name:
`
`Generic Name:
`
`
`Sponsor:
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`Approval Date:
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`Indications:
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`Norethindrone acetate and ethinyl estradiol chewable
`tablets and ethinyl estradiol tablets and ferrous
`fumarate tablets
`
`Warner Chilcott Company, LLC
`
`July 24, 2013
`
` Lo Minastrin Fe is an estrogen/progestin COC
`indicated for use by women to prevent pregnancy
`
`
`
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`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`204654Orig1s000
`
`CONTENTS
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`Reviews / Information Included in this NDA Review.
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`X
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`X
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`X
`X
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`X
`X
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`X
`X
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`X
`X
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`X
`X
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`Approval Letter
`Other Action Letters
`Labeling
`REMS
`Summary Review
`Officer/Employee List
`Office Director Memo
`Cross Discipline Team Leader Review
`Medical Review(s)
`Chemistry Review(s)
`Environmental Assessment
`Pharmacology Review(s)
`Statistical Review(s)
`Microbiology / Virology Review(s)
`Clinical Pharmacology/Biopharmaceutics Review(s)
`Other Reviews
`Risk Assessment and Risk Mitigation Review(s)
`Proprietary Name Review(s)
`Administrative/Correspondence Document(s)
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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 204654
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`
`
`Food and Drug Administration
`Silver Spring MD 20993
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`NDA APPROVAL
`
`
`Warner Chilcott Company, LLC
`Attention: Alvin Howard
`Senior Vice President, Regulatory Affairs
`100 Enterprise Drive
`Rockaway, NJ 07866
`
`Dear Mr. Howard:
`
`Please refer to your New Drug Application (NDA) dated September 27, 2012, received
`September 28, 2012, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic
`Act (FDCA) for Lo Minastrin Fe (norethindrone acetate and ethinyl estradiol chewable tablets
`and ethinyl estradiol tablets and ferrous fumarate tablets).
`
`We acknowledge receipt of your amendments dated November 27, 2012, January 23, April 4,
`May 8, 22, June 27, July 11, 16 and 23, 2013.
`
`This new drug application provides for the use of Lo Minastrin Fe (norethindrone acetate and
`ethinyl estradiol chewable tablets and ethinyl estradiol tablets and ferrous fumarate tablets) for
`the prevention of pregnancy.
`
`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.
`
`CONTENT OF LABELING
`
`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
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to 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, available at
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
`
`The SPL will be accessible via publicly available labeling repositories.
`
`
`
`Reference ID: 3346332
`
`
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`NDA 204654
`Page 2
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`CARTON AND IMMEDIATE-CONTAINER LABELS
`
`Submit final printed carton and immediate-container labels that are identical to the carton and
`immediate-container labels submitted on July 16, 2013, 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 Providing Regulatory Submissions in Electronic Format – 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 204654.”
`Approval of this submission by FDA is not required before the labeling is used.
`
`Marketing the product(s) with FPL that is not identical to the approved labeling text may render
`the product misbranded and an unapproved new drug.
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`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(s) 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.
`
`PROMOTIONAL MATERIALS
`
`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:
`
`
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
`
`
`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 Office of Prescription Drug
`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
`
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`Reference ID: 3346332
`
`
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`NDA 204654
`Page 3
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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).
`
`If you have any questions, call Pamela Lucarelli, Regulatory Health Project Manager, at
`(301) 796-3961.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Audrey Gassman, M.D.
`Deputy Director
`Division of Bone, Reproductive, and Urologic Products
`Office of Drug Evaluation III
`Center for Drug Evaluation and Research
`
`
`
`Enclosures:
`Content of Labeling
`Carton and Container Labeling
`
`
`
`Reference ID: 3346332
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`AUDREY L GASSMAN
`07/24/2013
`
`Reference ID: 3346332
`
`(
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