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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

HYDERABAD, India & PRINCETON, N.J.–(BUSINESS WIRE)–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 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. 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 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. Reddy’s: Dr. Reddy’s 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. Reddy’s
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. Reddy’s 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
management’s 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.

Contacts

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

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

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