`
`Coalition For Affordable Drugs XI LLC
`Exhibit 1009
`Coalition For Affordable Drugs XI LLC v Insys Pharma, Inc.
`IPR2015-01797
`
`
`
`DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`Public Health Service
`
`Food and Drug Administration
`Rockville, MD 20857
`
`NDA20-747/S-017
`
`Cephalon, Inc.
`145 Brandywine Parkway
`West Chester, PA 19380
`
`Attention: Carol S. Marchione
` Sr. Director, Regulatory Affairs
`
`Dear Ms. Marchione:
`
`Please refer to your supplemental new drug application dated March 24, 2004, received March 25, 2004,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Actiq (oral transmucosal
`fentanyl citrate).
`
`This “Changes Being Effected” supplemental new drug application provides for changes to the PRECAUTIONS
`section of the package insert and patient leaflet and the ADVERSE REACTIONS-Post Marketing Experience
`section to address the association of Actiq with occurrences of dental caries, tooth loss and gum line erosion.
`
`We have completed our review of this application and it is approved, effective on the date of this letter.
`
`If you issue a letter communicating important information about this drug product (i.e., a “Dear Health Care
`Professional” letter), we request that you submit a copy of the letter to this NDA and a copy to the following
`address:
`
`MEDWATCH, HFD-410
`FDA
`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).
`
`If you have any questions, call Kimberly Compton, Regulatory Project Manager, at (301) 827-7432.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Bob Rappaport, M.D.
`Director
`Division of Anesthetic, Critical Care and
`Addiction Drug Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
`
`Enclosure
`
`
`
`---------------------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`---------------------------------------------------------------------------------------------------------------------
` /s/
`---------------------
`Rigoberto Roca
`9/24/04 06:14:53 PM
`for Bob Rappaport, M.D.
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