Specialty pharmaceutical company Sun Pharmaceutical Industries has obtained final USFDA approval for the abbreviated new drug application of generic Depo-Testosterone Injection, Testosterone Cypionate Injection USP, 100mg/ml and 200mg/ml.
Therapeutically equivalent to Depo-Testosterone Injection of Pfizer, the Testosterone Cypionate Injection USP, 100 mg/mL and 200mg/mL is indicated for males with deficiency or absence of endogenous testosterone.
The generic product is approved as a replacement therapy in the male patients with conditions associated with symptoms of deficiency or absence of endogenous testosterone.
In the US, annual revenues of the product were approximately $130m, according to April-2013, IMS MAT data.
The Indian pharmaceutical company manufactures and markets a range of pharmaceutical products covering therapy areas of psychiatry, neurology, cardiology, nephrology, gastroenterology, orthopedics and ophthalmology.
