CHADDS FORD, Pa., July 1 /PRNewswire-FirstCall/ — 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
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