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`( -t DEPARTMENT OF HEATH AND HUMA SERVICES
`
`NDA 022395
`
`Neurogesx, Inc.
`2215 Bridgepointe Parkway
`Suite 200
`San Mateo, CA 94404
`
`Attention: Susan Rinne, M.S.
`Vice President, Regulatory Affairs
`
`Dear Ms. Rinne:
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`NDA APPROVAL
`
`Please refer to your new drug application (NDA) dated October 13,2008, received October 16,
`the Federal Food, Drug, and Cosmetic Act for
`
`2008, submitted pursuant to section 505(b)(2) of
`
`QUTENZA ™ (capsaicin) 8% patch.
`
`We acknowledge receipt of
`
`your submissions dated December 11,2008 and January 29,
`February 4, 11, and 12, March 4,6, 10, 11, 16,26,27 and 30, April 7 and 13, May 19, June 24,
`July 30, and August 18,2009.
`
`This new drug application provides for the use of QUTENZA ™ (capsaicin) 8% patch for the
`management of neuropathic pain associated with postherpetic neuralgia.
`
`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 314.50(1) J in structured product labeling (SPL) format, as described
`at htt://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. that is
`identical to the enclosed labeling (text for the package insert and text for the patient package
`insert). For administrative purposes, please designate this submission, "SPL for approved NDA
`02295."
`
`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
`A~ations and Related Submissions Using the eCTD Specifcations (October 2005).
`
`

`

`NDA 022395
`Page 2
`
`
`Alternatively, you may submit 12 paper copies, with 6 of
`
`
`the copies individually mounted on
`heavy-weight paper or similar materiaL. For administrative puroses, designate this submission
`this
`
`"Final Printed Carton and Container Labels for approved NDA 022395." Approval
`
`of
`
`submission by FDA is not required before the labeling is used.
`
`Marketing the product with FPL that is not identical to the approved labeling text may render the
`product misbranded and an unapproved new drug.
`
`lUQlJIRED£ljDIATRIÇ A§S¡§SMENIS
`
`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 indicatiort(s) in pediatric patients unless this requirement is waived,
`deferred, or inapplicable.
`
`Because this drug product for this indication has an orphan drug designation, you are exempt
`from this requirement.
`
`PBOMoIIONÂLMt\IEWÂ1S
`
`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
`Division of Drug Marketing, Advertising, and Communications
`5901-B Ammendale Road
`Beltsvile, MD 20705-1266
`
`2253. For instruction on completing the Form FDA 2253, see page 2 of
`
`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
`the Form. For more
`information about submission of promotional materials to the Division of Drug Marketing,
`Advertising, and Communications (DDMAC), see
`htt://www.fda.gov/AboutFDA/CentersOffices/CDERlucm090142.htm.
`
`E;K£!&IIQN. nAIIN.!,PEß!QP
`
`An expiry of 36 months is granted for the finished product, including both the patch and
`cleansing gel components under the recommended storage conditions: Store carton between 20°
`to 25°C (68° to 77°F); excursions between 15° and 30°C (59° and 86°F) are permitted.
`
`

`

`NDA 022395
`Page 3
`
`
`LljTTER§ TO HEALTIl CÂßEPROFESSIONALS
`
`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 12B-05
`5600 Fishers Lane
`
`Rockvile, MD 20857
`
`
`REPORTINGßEQllIUMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA (2 i
`CFR 314.80 and 314.81).
`
`If you have
`
`
`any questions, call Tanya Clayton, Regulatory Project Manager, at (301) 796-087 i.
`
`Sincerely,
`
`(See appended electronic signature page)
`
`Curtis J. Rosebraugh, M.D., M.P.H.
`Director
`Offce of Drug Evaluation II
`New Drugs
`Center for Drug Evaluation and Research
`
`Office of
`
`
`Enclosures: Package Insert
`Carton and Container Labels
`
`

`

`Application
`Type/Number
`
`Submission
`Type/Number
`
`Submitter Name Product
`
`
`Name
`
`NDA-22395
`
`ORIG-1
`
`NEUROGESX INC Qutenza
`
`----------------------------------------------------_.--------------------------------------.-----------­
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`-------------------------_._------------------------_.--------------------------------------------------­
`/s/
`
`CURTIS J ROSEBRAUGH
`11/16/2009
`
`