CENTER FOR DRUG EVALUATION AND
`
`RESEARCH
`
`APPLICA TION NUMBER:
`
`22-301
`
`APPROVAL LETTER
`
`

`

`52mg
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`
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`
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`-—/C DEPARTMENT OF HEALTH & HUMAN SERVICES
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`”tin
`
`PublicHealth Service
`
`Food and Drug Administration
`Rockville, MD 20857
`
`NDA 22-301
`
`NDA APPROVAL
`
`’ Salix Pharmaceuticals, Inc.
`Attention: Benjamin M. Burgin, RAC
`Senior Manager, Regulatory Affairs
`1700 Perimeter Park Drive
`
`Morrisville, NC 27560
`
`Dear Mr. Burgin:
`
`Please refer to your new drug application (NDA) dated December 21, 2007, received December
`31, 2007, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act
`for Apriso (mesalamine) extended-release capsules 0.375 g.
`
`We acknowledge receipt of your submissions dated January 21, 2008, March 7, 2008, April 24,
`2008, April 25, 2008, May 7,2008, May 13, 2008, June 13, 2008, July 25, 2008, August 1, 2008,
`August 14, 2008, August 22, 2008, September 16, 2008, October 1, 2008, October 3, 2008,
`I October 15, 2008, October .16, 2008, October 17, 2008, and October 28, 2008.
`
`This new drug application provides for the use of Apriso (mesalamine) extended-release capules
`0.375 g for the maintenance of remission of ulcerative colitis in adults.
`
`We have completed our review of this application. 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, please submit the
`content of labeling [21 CFR 3 1450(1)] in structured product labeling (SPL) format as described
`at http://www.fda.gov/oc/datacouncil/spl.html that is identical to the enclosed labeling. Upon
`receipt, we will transmit that version to the National Library of Medicine for public
`dissemination. For administrative purposes, please designate this submission, “SPL for approved
`_ NDA 22—301.”
`
`

`

`NDA 22-301
`
`Page 2
`
`CARTON AND IMMEDIATE CONTAINER LABELS
`
`Submit final printed carton and container labels that are identical to the enclosed carton and
`immediate container labels 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— Human Pharmaceutical Product
`Applications and Related Submissions Using the eCTD Specifications (October 2005).
`- 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 22-301.” Approval of this
`submission by FDA is not required before the labeling is used.
`
`Marketing the product(s) with FPL thatis 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. 3550), 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.
`
`- We are waiving the pediatric study requirement for ages 0 to 5 years because the necessary
`studies are impossible or highly impracticable. This is because there are too few children with
`ulcerative colitis in that age range to study.
`
`We are deferring submission of your pediatric study for ages 5 to 17 years for this application
`because this product18 ready for approval for use in adults and the pediatric study has not been
`completed.
`
`~ Your deferred pediatric study required by section 505B(a) of the Federal Food, Drug, and
`Cosmetic Act is a required postmarketing study. The status of this postmarketing study must be
`reported annually according to 21 CFR 314.81 and section 505B(a)(3)(B) of the Federal Food,
`Drug, and Cosmetic Act. This required study13 listed below.
`
`.
`
`l. Deferred pediatric study under PREA for the maintenance of remission of ulcerative cOlitis
`in pediatric patients ages 5 to 17 years to evaluate safety, effectiveness, and
`pharmacokinetics with Apriso (mesalamine granules)in at least two dosing regimens
`Protecol Submission:
`Junel, 2009
`Study Start:
`January 1, 2010
`Final Report Submission:
`June 1, 2013
`
`.
`
`Submit final study reports to this NDA. For administrative purposes, all submissions related to
`this required pediatric postmarketing study must be clearly designated “Required Pediatric
`Assessment.”
`
`

`

`NDA 22-301
`
`Page 3
`
`PROMOTIONAL MATERIALS
`
`I 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(s)
`to:
`
`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
`
`As required under 21 CFR 3 l4.81(b)(3)(i), you must submit final promotional materials, and the
`package insert(s), 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 www.fda.gov/cder/ddmac.
`
`'
`
`Please submit one market package of the drug product when it is available.
`
`LETTERS TO HEALTH CARE PROFESSIONALS
`
`If you issue a letter communicating important safety related information about this drug product
`(Le, a “Dear Health Care Professional” letter), we request that you submit an electronic copy of
`. the letter to both this NDA and to the following address:
`
`MedWatch
`
`Food and Drug Administration
`Suite 12B05
`5600 Fishers Lane
`
`Rockville, MD 20857
`
`. REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA (21
`CFR 314.80 and 314.81).
`
`

`

`NDA 22-301
`
`Page 4
`
`If you have any questions, call Cristi Stark, Regulatory Project Manager, at (301) 796-1007.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Donna Griebel, MD
`Director
`
`Division of Gastroenterology Products
`Office of Drug Evaluation 111
`Center for Drug Evaluation and Research
`
`Enclosure
`
`