`
`Public Health Service
`Food and Drug Administration
`Rockville, MD 20857
`
`NDA 21-399/S-008
`
`AstraZeneca Pharmaceuticals LP
`Attention: Patricia Palumbo, RN, BSN, JD
`Regulatory Affairs Director
`1800 Concord Pike P.O. Box 8355
`Wilmington, DE 19803-8355
`
`Dear Ms. Palumbo:
`
`Please refer to your supplemental new drug application dated March 28, 2005, received March 29,
`2005, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Iressa
`(gefitinib) Tablets.
`
`We acknowledge receipt of your submissions dated May 24 and 25; and June 9, 2005.
`
`This supplemental new drug application provides for revised labeling. Specifically, this labeling
`includes revisions to the CLINICAL STUDIES and INDICATIONS AND USAGE sections to reflect
`the results of Trial 709 in non-small cell lung cancer (NSCLC), which failed to demonstrate an
`increase in survival.
`
`We have completed our review of this application, as amended. This application is approved, effective
`on the date of this letter, for use as recommended in the enclosed agreed-upon labeling text.
`
`The final printed labeling (FPL) must be identical to the enclosed labeling (text for the package insert).
`
`Please submit an electronic version of the FPL according to the guidance for industry titled Providing
`Regulatory Submissions in Electronic Format - NDA. Alternatively, you may submit 20 paper copies
`of the FPL as soon as it is available but no more than 30 days after it is printed. Individually mount 15
`of the copies on heavy-weight paper or similar material. For administrative purposes, designate this
`submission "FPL for approved supplement NDA 21-399/S-008.” Approval of this submission by
`FDA is not required before the labeling is used.
`
`OSI 2032
`APOTEX V. OSI
`IPR2016-01284
`
`1
`
`
`
`NDA 21-399/S-008
`Page 2
`
`You have stated that you will limit distribution of this drug under a risk management plan called the
`Iressa Access Program, to the following patient populations:
`
`(cid:129)
`(cid:129)
`(cid:129)
`
`patients currently receiving and benefiting from Iressa;
`patients who have previously received and benefited from Iressa; and
`previously enrolled patients or new patients in non-IND clinical trials approved by an IRB prior
`to June 17, 2005.
`
`Marketing of this drug product and related activities are to be in accordance with the substance and
`procedures of all FDA regulations and the commitments you have made regarding the Iressa Access
`Program.
`
`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 Amy Baird, Regulatory Project Manager, at (301) 594-5779.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Richard Pazdur, M.D.
`Director
`Division of Oncology Drug Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`Enclosure: Labeling
`
`2
`
`
`
`---------------------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`---------------------------------------------------------------------------------------------------------------------
` /s/
`---------------------
`Richard Pazdur
`6/17/05 09:18:37 AM
`
`3
`
`
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