Dr. Reddy’s Announces the Launch of Duloxetine Delayed-Release Capsules USP
HYDERABAD, India -- June 27, 2014
Dr. Reddy’s Laboratories (NYSE: RDY) announced today that it has launched
Duloxetine Delayed-Release Capsules USP 20 mg, 30 mg and 60 mg, a therapeutic
equivalent generic version of CYMBALTA^® (Duloxetine Delayed-Release Capsules)
in the US market on June 26, 2014. Dr. Reddy’s ANDA is approved by the United
States Food & Drug Administration (USFDA).
The CYMBALTA^® brand and generic had U.S. sales of approximately $5.04 Billion
MAT for the most recent twelve months ending in April 2014 according to IMS
Dr. Reddy’s Duloxetine Delayed-Release Capsules USP 20 mg, 30 mg and 60 mg are
available in several bottle counts.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior in
children, adolescents, and young adults in short-term studies. These studies
did not show an increase in the risk of suicidal thoughts and behavior with
antidepressant use in patients over age 24; there was a reduction in risk with
antidepressant use in patients aged 65 and older.
In patients of all ages who are started on antidepressant therapy, monitor
closely for worsening, and for emergence of suicidal thoughts and behaviors.
Advise families and caregivers of the need for close observation and
communication with the prescriber.
Duloxetine is not approved for use in pediatric patients.
This press release includes forward-looking statements, as defined in the U.S.
Private Securities Litigation Reform Act of 1995. We have based these
forward-looking statements on our current expectations and projections about
future events. Such statements involve known and unknown risks, uncertainties
and other factors that may cause actual results to differ materially. Such
factors include, but are not limited to, changes in local and global economic
conditions, our ability to successfully implement our strategy, the market
acceptance of and demand for our products, our growth and expansion,
technological change and our exposure to market risks. By their nature, these
expectations and projections are only estimates and could be materially
different from actual results in the future.
About Dr. Reddy’s
Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated global
pharmaceutical company, committed to providing affordable and innovative
medicines for healthier lives. Through its three businesses - Pharmaceutical
Services and 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. Major therapeutic focus is on gastro-intestinal, cardiovascular,
diabetology, oncology, pain management and anti-infective. Major markets
include India, USA, Russia-CIS and Europe apart from other select geographies
within Emerging Markets. For more information, log on to: www.drreddys.com
CYMBALTA^® is a registered trademark of Eli Lilly and Company.
*IMS National Sales Perspectives: Retail and Non-Retail MAT April 2014
Dr. Reddy’s Laboratories Ltd.
Investors and Financial Analysts:
Kedar Upadhye, +91-40-66834297
Saunak Savla, +91-40-49002135
Milan Kalawadia (USA), +1 609-375-9831
SVS Chowdary, +91-40- 49002448
Press spacebar to pause and continue. Press esc to stop.