Sun Pharmaceutical receives USFDA approval for generic DepoTestosterone Injection

04 Jun 2013 Evaluate

Sun Pharmaceutical Industries 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 $130 million in the US.

Sun Pharmaceuticals Industries is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world.

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