Determination That Hyaluronidase For Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

概要

The Food and Drug Administration (FDA) is announcing its determination that hyaluronidase for injection (Wydase) was not withdrawn from sale for reasons of safety or effectiveness. While this determination will allow FDA to approve abbreviated new drug applications (ANDAs) for hyaluronidase for injection, in considering whether to file an ANDA for this product, future applicants are advised that such an application raises complex issues regarding the characterization of the active ingredient.