Regulatory

With over twenty years of approved Captisol-enabled drug products, there is significant regulatory experience with Captisol in regulatory agencies worldwide. Ligand maintains two types of Drug Master Files (DMFs) with the FDA: Type IV including CMC information and Type V including regulatory safety information that supports all routes of delivery. DMFs have also been established in Canada, China, and Japan. Many FDA divisions and other regulatory bodies have evaluated the data package and approved the use of Captisol in more than 500 clinical trials.