Approval occurred within the FDA's ten-month review time frame as defined under the Prescription Drug User Fee Act.

Testosterone Buccal System offers a safe, effective and convenient alternative in testosterone low level therapy. At present about 5 million men suffering from a low level of testosterone.

Testosterone low level are determined in men of all ages, with a significant number of patients having symptoms over age 60. In most patients in the clinical tests, Testosterone Buccal System quickly achieved and maintained a stabilise, consistent level of testosterone within 10 to 12 hours of starting therapy.