FDA has accepted a new drug application for a topically applied alprostadil cream for the treatment of erectile dysfunction, according to NexMed, Inc., the drug’s developer.
FDA has accepted a new drug application for a topically applied alprostadil cream for the treatment of erectile dysfunction, according to NexMed, Inc., the drug’s developer.
The acceptance for review is an indication that FDA has determined that the filing is sufficient to complete a substantive review of the application, which customarily takes a minimum of 8 months, should the agency not require any additional studies or information, the company said.
From evidence to practice: Dr. Makarov discusses implementation science in urology
July 25th 2024“What our major contribution is, I think as urologists doing implementation science, is determining the important questions, which we are particularly well-suited to do because we're taking care of the patients,” says Danil V. Makarov, MD, MHS.