Cipla receives final approval for Testosterone Cypionate Injection

Capital Market 

From USFDA

has received final approval for its Application (ANDA) for 100mg/ml and 200mg/ml from the Food and Drug Administration (US FDA).

Cipla's 100mg/ml and 200mg/ml is AO-rated generic therapeutic equivalent version of and Upjohn's Depo-Testosterone. It is indicated for replacement therapy in males in conditions associated with symptoms of 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.

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Thu, June 21 2018. 09:15 IST