Sun Pharmaceutical Industries Ltd., a Rs.11,200 crore plus pharma major, has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for generic version of Depo-Testosterone injection, Testosterone Cypionate injection USP, 100 mg/ml and 200mg/ml.
This generic Testosterone Cypionate injection USP, 100 mg/mL and 200mg/mL is therapeutically equivalent to Depo-Testosterone injection of Pfizer Inc and is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. As per April-2013, IMS MAT, the product had annual revenues of approximately US$130 million in the US.
Depo-Testosterone injection is a registered trademark of Pfizer Inc.