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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`NDA 050805/S-002
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`Galderma Laboratories, L.P.
`Attention: Richard Almond
`Manager, Regulatory Affairs
`14501 N. Freeway
`Fort Worth, TX 76177
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`Dear Mr. Almond:
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`Please refer to your supplemental new drug application dated June 17, 2009, received June 18,
`2009, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
`Oracea (doxycycline, USP) Capsules, 40 mg.
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`We acknowledge receipt of your submissions dated August 24, 2009, and April 29, 2010.
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`This supplement provides for the revision of the Oracea Capsules full prescribing information to
`meet the new labeling content and format requirements for human prescription drug and
`biological products according to 21 CFR 201.56(d) and 201.57.
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`We also refer to our teleconference held on April 28, 2010, where we acknowledged that
`changes to your carton and container labels approved on May 26, 2006, are not required at this
`time.
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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, using 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 and include the labeling changes proposed in any pending
`“Changes Being Effected” (CBE) supplements. Information on submitting SPL files using
`eLIST may be found in the guidance for industry titled “SPL Standard for Content of Labeling
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`Technical Qs and As” at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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` NDA 050805/S-002
`Page 2
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`The SPL will be accessible from publicly available labeling repositories.
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` LETTERS TO HEALTH CARE PROFESSIONALS
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`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
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` the letter to both this NDA and to the following address:
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`MedWatch
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`Food and Drug Administration
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`5600 Fishers Lane, Room 12B05
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`Rockville, MD 20857
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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 Tamika White, Regulatory Project Manager, at (301) 796-0310.
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`Sincerely,
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`{See appended electronic signature page}
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`Susan J. Walker, M.D., F.A.A.D.
`Director
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`Division of Dermatology and Dental Products
`Office of Drug Evaluation III
`Center for Drug Evaluation and Research
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`Enclosure
`Content of Labeling
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`Application
`Type/Number
`--------------------
`NDA-50805
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`Submission
`Type/Number
`--------------------
`SUPPL-2
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`Submitter Name
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`Product Name
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`------------------------------------------
`--------------------
`ORACEA (DOXYCYCLINE
`GALDERMA
`LABORATORIES MONOHYDRATE)
`LP
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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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`SUSAN J WALKER
`05/13/2010
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