The FDA approved the first generic version of the Johnson & Johnson drug Doxil on Monday, which is used to treat multiple myeloma, ovarian cancer and AIDS-related Kaposi's sarcoma. The generic version, which is made by Sun Pharma Global FZE, could help solve a Doxil shortage brought about by quality control problems in the manufacturing process.
The FDA didn't approve Hemispherx Biopharma's application for its candidate chronic fatigue syndrome drug Ampligen. The drugmaker will seek an "end-of-review" meeting with regulators and could file a formal appeal. Hemispherx said the agency requested data analyses, the completion of nonclinical trials and at least one more study involving patients.
Johnson & Johnson is seeking approval from the FDA and the European Medicines Agency for a manufacturing process that would offer a short-term solution to shortage of cancer treatment Doxil. Under the plan, Ben Venue Laboratories would manufacture the drug, while another supplier would manage other tasks, J&J spokeswoman Lisa Vaga said. Doxil production could resume by year-end.
The FDA is allowing Endocyte to import Doxil, an ovarian cancer drug by Johnson & Johnson, for use in a Phase III study of Endocyte's drug candidate EC145 in combination with Doxil. U.S. and EU regulators need data from the trial to determine whether they should approve EC145.
The FDA is looking at options and working closely with Johnson & Johnson and contract manufacturer Ben Venue Laboratories to relieve a shortage of cancer medicine Doxil. The problem, which began in the summer, worsened after Ben Venue, a Boehringer Ingelheim unit, halted production at a Bedford, Ohio, facility. The European Medicines Agency said quality control issues were identified by U.S., French and U.K. inspectors.