Business · 08/10/2014
FDA Clears LUPRON DEPOT for Generic Applications, Despite Lack of Commercial Availability
The FDA has determined that LUPRON DEPOT, a 3.75mg/vial injectable, was not withdrawn from sale due to safety or effectiveness concerns, paving the way for generic applications. However, applicants may face challenges in obtaining the product for bioequivalence testing due to its long commercial unavailability.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →