FDA CRL - Gregory Pharmaceutical Holdings Inc. dba UPM Pharmaceuticals Inc.

On May 15, 2009, the FDA issued a Complete Response Letter to King Pharmaceuticals regarding its New Drug Application (NDA 22-377) for a sumatriptan auto-injector intended to treat migraines. The agency determined that the application could not be approved in its current form under the regulatory framework of the Federal Food, Drug, and Cosmetic Act.

The primary issue preventing approval is the lack of an approved proprietary (brand) name. The FDA expressed concern that because King’s single-use, pressure-activated device operates differently than the existing button-activated Imitrex auto-injector, a distinct name is necessary to prevent medication errors and ensure patient safety. Without proper distinction, patients might attempt to use the device incorrectly, leading to failed dosing or accidental needle-stick injuries. Additionally, the FDA identified several labeling violations, including the failure to prominently display the route of administration, the omission of liquid volume measurements, and the use of confusing instructional graphics that contradicted safety warnings regarding hand placement.

To address these deficiencies, King Pharmaceuticals must propose an acceptable proprietary name and submit revised labeling and instructions for use that feature improved color contrast for safety alerts. The company is required to resubmit the amended application in a structured electronic format within one year or the application will be considered withdrawn.