[June 27, 2014] |
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Dr. Reddy's Announces the Launch of Duloxetine Delayed-Release Capsules USP
HYDERABAD, India --(Business Wire)--
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 Health*.
Dr. Reddy's Duloxetine Delayed-Release Capsules USP 20 mg, 30 mg and 60
mg are available in several bottle counts.
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WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
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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.
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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.
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Duloxetine is not approved for use in pediatric patients.
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Disclaimer 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
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