Cipla Receives Final Approval for Generic Depo-Testosterone® (Testosterone Cypionate for Injection 100mg/ml and 200mg/ml)

Mumbai, India, June 21, 2018: Cipla Limited (“Cipla”), today announced that it 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 Depo- Testosterone®. 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 $191M for the 12-month period ending April 2018.

The product is available for shipping immediately.