CHADDS FORD, Pa. Endo Pharmaceuticals has resubmitted its application to the Food and Drug Administration for a testosterone gel, following its failure to win approval for the drug the first time around, Endo said Thursday.
The FDA gave Endo a complete response letter in October in response to the company’s approval application for Fortesta testosterone gel, used to treat low testosterone, also known as hypogonadism. A complete response letter means that the FDA has finished reviewing the application, but questions remain that preclude the drug’s approval.
“We are optimistic that our expeditious and careful response to the FDA’s requests will lead to the agency’s approval of Fortesta,” Endo COO Julie McHugh stated. “We are committed to making this testosterone gel formula available as soon as possible, and will continue to work closely with the FDA toward our goal of making this product available for the treatment of low testosterone in men.”
ProStrakan Group originally filed the application for the drug in April 2009, and Endo signed an agreement with ProStrakan in August to acquire exclusive U.S. rights to commercialize the gel.