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

Dr. Reddys Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as Dr. Reddys) 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 Administration (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. Reddys 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 contact with unwashed or unclothed application sites in men using testosterone gel.
  • Healthcare providers should advise patients to strictly adhere to recommended instructions for use.

AndroGel is a trademark of AbbVie Inc.

*IQIA Retail and Non-Retail MAT February 2019 RDY-0419-245

About Dr. Reddys: Dr. Reddys Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products “ Dr. Reddys offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddys operates in markets across the globe. Our major markets include “ USA, India, Russia & CIS countries, and Europe. For more information, log on to: www.drreddys.com

Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the managements current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words “may”, “will”, “should”, “expects”, “plans”, “intends”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, or “continue” and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates , interest rates , persistency levels and frequency / severity of insured loss events (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization , including related integration issues.

The company assumes no obligation to update any information contained herein.

INVESTOR RELATIONS
AMIT AGARWAL
[email protected]
(PH:
+91-40-49002135)

MEDIA RELATIONS
MITALI SARKAR
[email protected]
(PH:
+91-40- 49002121)