Thread: Sun Pharma gets USFDA nod for testosterone cypionate injection

PTI Jun 4, 2013, 05.18PM IST

NEW DELHI: Drug firm Sun Pharmaceutical Industries today said it has received final approval from the US health regulator for its generic testosterone cypionate injection indicated for treatment of testosterone hormone deficiency.

"The company has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for generic version of Depo-Testosterone Injection, Testosterone Cypionate Injection USP," Sun Pharma said in a statement.

The approval is for the product in the strengths of 100 mg/ml and 200mg/ml, it added.

The company's generic testosterone cypionate injection is therapeutically equivalent to Pfizer Inc's Depo Testosterone injection, Sun Pharma said.
"As per April-2013 IMS MAT data, the product had annual revenues of approximately USD 130 million in the US," it added.

The injection is indicated for replacement therapy in males in conditions associated with symptoms of deficiency or absence of endogenous testosterone, Sun Pharma said.
Shares of Sun Pharmaceutical Industries today closed at Rs 1,018.80 a scrip on BSE, up 0.13 per cent from its previous close.

I wonder what the label will look like.