Endo Pharmaceuticals completes next step in regulatory process for FORTESTA for men with low testosterone

Following it’s receipt of a Complete Response letter in October 2009 related to the New Drug Application (NDA) submission for FORTESTA (testosterone) 2% gel, Endo Pharmaceuticals has recently submitted a complete response to the U.S. Food and Drug Administration (FDA).

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. Tipically, the FDA’s review period for Class 2 resubmissions is six months.