King Pharmaceuticals, Inc.: sumatriptan

Please refer to your new drug application (NDA) dated July 16, 2008, received July 17, 2008, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for sumatriptan injection.

We have completed the review of your application, as amended, and have determined that we cannot approve this application in its present form.

Your 6 mg sumatriptan succinate auto-injector differs from the previously approved Imitrex 6 mg (sumatriptan succinate) auto-injector in that your product, among other things, is a preassembled single use disposable injector.

Your proposed labeling, and the approved labeling of the Imitrex autoinjector, include statements directing prescribers to instruct patients on the proper use of the product prior to first use in a medically unsupervised situation.

Given that patients instructed on the use of another sumatriptan auto-injector may be unable to use your product without prior training, and vice versa, inadvertent substitution may lead to failed use of the product during a migraine attack, or to a safety risk to the patient.

As you have not proposed an alternative acceptable proprietary name, or evidence that your product is safe for use without a proprietary name, the application can not be approved.

We note that you have agreed to the following revisions regarding your container labels, carton labeling, and instructions for use:

1. The word "Auto-Injector" appears next to the established name, sumatriptan injection.

2. The net quantity volume is not identified on the carton labeling or container label.