Dr. Reddy’s Laboratories announces the launch of Testosterone Gel, 1.62% (20.25 mg/1.25 g pump actuation) in the U.S. Market 5r733v

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Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch of Testosterone Gel 1.62%, a therapeutic equivalent generic version of AndroGel® (testosterone gel) 1.62%, approved by the U.S. Food and Drug istration (USFDA).

The AndroGel® (testosterone gel) brand and generic had U.S. sales of approximately $815.6 million MAT for the most recent twelve months ending in February 2019 according to IQVIA Health*.

Dr. Reddy’s Testosterone Gel 1.62% (20.25 mg/1.25 g pump actuation) is available in a net quantity of 88 g pump which dispenses 20.25 mg of testosterone per actuation. Each metered-dose pump is capable of dispensing 60 metered pump actuations.

WARNING: SECONDARY EXPOSURE TO TESTOSTERONE

 

See full prescribing information for complete boxed warning.

 

·    Virilization has been reported in children who were secondarily exposed to testosterone gel.

·    Children should avoid with unwashed or unclothed application sites in men using testosterone gel.

·    Healthcare providers should advise patients to strictly adhere to recommended instructions for use.