`
`
`
`DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`
`
`
`
`Public Health Service
`Food and Drug Administration
`Rockville, MD 20857
`
`
`
`NDA 21-462/S-012
`
`
`Eli Lilly and Company
`Attention: Colleen Mockbee, R.Ph., RAC
`Manager, U.S. Regulatory Affairs
`Lilly Corporate Center
`Indianapolis, IN 46285
`
`
`Dear Ms. Mockbee:
`
`Please refer to your supplemental new drug application dated May 7, 2007, received May 8, 2007,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Alimta (pemetrexed
`for injection).
`
`We acknowledge receipt of your submissions dated September 4 and 6 (electronic), 2007.
`
`This supplemental new drug application provides for a new strength, 100 mg vials.
`
`We 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 agreed upon enclosed labeling.
`
`The final printed labeling (FPL) must be identical to the enclosed labeling (package insert, patient
`package insert, immediate container and carton labels).
`
`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 21-462/S-012.” Approval of this submission by
`FDA is not required before the labeling is used.
`
`In addition, within 21 days of the date of this letter, amend any pending applications for this NDA with
`content of labeling in structured product labeling (SPL) format to include the changes approved in this
`application.
`
`All applications for new active ingredients, new dosage forms, new indications, new routes of
`administration, and new dosing regimens are required to contain an assessment of the safety and
`effectiveness of the product in pediatric patients unless this requirement is waived or deferred. We are
`waiving the pediatric study requirement for this application.
`
`
`
`

`

`NDA 21-462/S-012
`Page 2
`
`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:
`
`
`
`
`
`
`
`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, please call Patricia Garvey, Senior Regulatory Project Manager, at (301)
`796-1356.
`
`MEDWATCH
`Food and Drug Administration
`5515 Security Lane
`HFD-001, Suite 5100
`Rockville, MD 20852
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Robert L. Justice, M.D.
`Director
`Division of Drug Oncology Products
`Office of Oncology Drug Products
`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/
`---------------------
`Robert Justice
`9/7/2007 04:50:55 PM
`
`