DUSA Pharmaceuticals did so by knowingly promoting an administration process that contradicted the product instructions approved by the Food and Drug Administration (FDA) for Levulan Kerastick. The administration process it promoted was also unsupported by sufficient clinical evidence.
Levulan Kerastick is an FDA-approved prescription topical solution for the treatment of minimally to moderately thick actinic keratosis (AKs) of the face or scalp.
The FDA’s approved instructions under the drug’s “Dosage Administration” section described a two-stage process involving the application of the topical solution to the target lesions and then, following an incubation period of 14 to hours, illumination of the target lesion with blue light.
The federal government alleged that the senior management of Dusa Pharmaceuticals and Sun Pharma knew that the administration of Levulan Kerastick for short incubation periods ranging from one to three hours resulted in clearance rates shorter than those achieved in clinical trials using 14 to 18 hours incubation.
