Endo Pharmaceuticals (Nasdaq: ENDP) has submitted a complete response to the U.S. Food and Drug Administration (FDA) following the company's receipt of a Complete Response letter in October 2009 related to the New Drug Application (NDA) submission for FORTESTA™ (testosterone) 2% gel. The company's Class 2 resubmission is the next step in its intention to offer FORTESTA as a treatment option in the United States for men diagnosed with low testosterone (Low T), also known as hypogonadism. The FDA's review period for Class 2 resubmissions typically is six months.
"We are optimistic that our expeditious and careful response to the FDA's requests will lead to the agency's approval of FORTESTA," said Julie McHugh, chief operating officer, Endo Pharmaceuticals. "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 plc submitted the NDA for FORTESTA to the FDA in April 2009, and Endo signed an agreement with ProStrakan in August 2009 to acquire exclusive U.S. rights to commercialize the testosterone 2% gel, branded variously as Tostran, Tostrex and Itnogen outside of the U.S. The principal content of the re-submission is a re-analysis of the primary variable (testosterone levels) in the original pivotal study. This re-analysis has confirmed the reliability of the original conclusions of the study. In addition, Endo has provided information in the Complete Response about its plans for a post-approval "hand-wash" study.