FDA accepts new drug application for ED topical cream

December 6, 2007

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.