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Sun Pharmaceutical Industries Ltd Announces USFDA Approval For Generic Depo-Testosterone Injection

Tuesday, 4 Jun 2013 06:30am EDT 

Sun Pharmaceutical Industries Ltd announced that it has received final approval from the USFDA 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 USD130 million in the US.