Cipla receives final approval for testosterone injection

Cipla has received final approval for its Abbreviated New Drug Application (ANDA) for Testosterone Cypionate Injection 100mg/ml and 200mg/ml from the United States Food and Drug Administration (US FDA).

Cipla’s Testosterone Cypionate Injection 100mg/ml and 200mg/ml is AO-rated generic therapeutic equivalent version of Pharmacia and Upjohn’s DepoTestosterone. It is indicated for replacement therapy in males in conditions associated with symptoms of deficiency or absence of endogenous testosterone.

According to IQVIA (IMS Health), Depo-Testosterone and its generic equivalents had US sales of approximately $191 million for the 12-month period ending April 2018.