Sun Pharmaceutical Industries 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 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 $130 million in the US.
EP News Bureau – Mumbai