`
` DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`
`
`
`
`
`
` Food and Drug Administration
`
`Silver Spring, MD 20993
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` NDA APPROVAL
`
`
`
`
` NDA 22-288
`
`
`
`
`
`Ista Pharmaceuticals, Inc.
`Attention: Paul Nowacki
`Director, Regulatory Affairs
`
` 15295 Alton Parkway
`Irvine, CA 92618
`
`
`Dear Mr. Nowacki:
`
`Please refer to your new drug application (NDA) dated November 12, 2008, submitted under
`
`section 505(b) of the Federal Food, Drug, and Cosmetic Act, for Bepreve (bepotastine besilate
`ophthalmic solution) 1.5%.
`
`We acknowledge receipt of your submissions dated November 12, December 10, 12 (two), 18, and
`19, 2008, and February 13, 17, March 11, April 28 (two), May 11, 14, 26, and 29, June 3, 5, 12 and
`30, July 2, 8, 28 and 31, and August 3, 12, and 13, 2009.
`
`This new drug application provides for the use of Bepreve (bepotastine besilate ophthalmic
`
`
`solution) 1.5% for treatment of ocular itching associated with allergic conjunctivitis.
`
`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.
`
`
`
`As soon as possible, but no later than 14 days from the date of this letter, please submit the content
`
`of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format as described at
` http://www.fda.gov/oc/datacouncil/spl.html that is identical to the enclosed labeling (text for the
`
`package insert submitted August 12, 2009). 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 22-288.”
`
`
` Submit final printed label 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 22-288.” Approval
`
`submission by FDA is not required before the labeling is used.
`
`
`
`

`

`
`
`
`NDA 22-288
`Page 2
`
`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.
`
`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. We are waiving the pediatric study requirement for this application because the
`number of pediatric patients, below the age of 2 years with itching associated with allergic
`
`conjunctivitis is small and the product will be adequately labeled for pediatric patients above the
`age of 2 years.
`
`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
`Division of Drug Marketing, Advertising, and Communications
`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(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
`http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
`
`Please submit one market package of the drug product when it is available.
`
`
`If you issue a letter communicating important safety related information about this drug product
`
`(i.e., 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
`
`
`We remind you that you must comply with reporting requirements for an approved NDA (21 CFR
`
`
`314.80 and 314.81).
`
`
`
`
`
`
`
`
`

`

`
`
`NDA 22-288
`Page 3
`
`
`
`If you have any questions, call Raphael R. Rodriguez, Regulatory Project Manager, at
`(301) 796-0798.
`
`
`
`
`
`
`Sincerely,
`
` {See appended electronic signature page}
`
`Edward M. Cox, M.D., M.P.H.
`Director
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
`
`
`
`
`
`
`
`Enclosure: Package Insert, Carton & Container labels.
`
`
`
`
`
`
`
`
`
`
`

`

`Application
`Type/Number
`--------------------
`NDA-22288
`
`Submission
`Type/Number
`--------------------
`ORIG-1
`
`Submitter Name
`
`Product Name
`
`------------------------------------------
`--------------------
`BEPOTASTINE BESILATE
`ISTA
`PHARMACEUTICA OPHTHALMIC SOLUTION
`LS
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`WILEY A CHAMBERS
`09/08/2009
`
`EDWARD M COX
`09/08/2009
`
`