New Delhi: Drug firm Cipla said it has received the final nod from the US health regulator for generic Testosterone Cypionate injection used for replacement therapy in males for deficiency or absence of endogenous testosterone.
The company has received final approval for its abbreviated new drug application (ANDA) for Testosterone Cypionate injection in the strengths of 100mg/ml and 200mg/ml from the US Food and Drug Administration (USFDA), Cipla said in a filing to BSE.
The product is a generic version of Pharmacia and Upjohn’s Depo-Testosterone injection, it added.
“It is indicated for replacement therapy in males in conditions associated with symptoms of deficiency or absence of endogenous testosterone,” Cipla said.
According to IQVIA, Depo-Testosterone and its generic equivalents had US sales of around USD 191 million for the 12-month period ending April 2018, it added.
The product is available for shipping immediately, Cipla said.