Dr. Reddy’s Announces the Launch of Lamotrigine Extended-Release Tablets
Dr. Reddy’s Laboratories (NYSE: RDY) announced today that is has
launched Lamotrigine Extended-Release Tablets (25 mg, 50 mg, 100 mg, 200
mg, 300 mg) a therapeutic equivalent generic version of Lamictal®
XR (lamotrigine) in the US market on June 25, 2013, following the
approval by the United States Food & Drug Administration (USFDA) of Dr.
Reddy’s ANDA for Lamotrigine XR tablets.
The Lamictal® XR brand and generic had combined U.S. sales of
approximately $300.5 Million MAT for the most recent twelve months
ending in April 2013 according to IMS Health*.
Dr. Reddy’s Lamotrigine XR Tablets 25 mg, 50 mg, 100 mg, 200 mg, and 300
mg are available as unit of use bottles of 30s.
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WARNING: SERIOUS SKIN RASHES
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See full prescribing information for complete boxed warning.
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Cases of life-threatening serious rashes, including
Stevens-Johnson syndrome and toxic epidermal necrolysis, and/or
rash-related death have been caused by lamotrigine. The rate of
serious rash is greater in pediatric patients than in adults.
Additional factors that may increase the risk of rash include
(5.1):
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• coadministration with valproate
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• exceeding recommended initial dose of lamotrigine
extended-release tablets
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• exceeding recommended dose escalation for lamotrigine
extended-release tablets
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Benign rashes are also caused by lamotrigine; however, it is
not possible to predict which rashes will prove to be serious or
life threatening. Lamotrigine extended-release tablets should be
discontinued at the first sign of rash, unless the rash is clearly
not drug related. (5.1)
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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, differentiated
formulations and NCEs. Therapeutic focus is on gastro-intestinal,
cardiovascular, diabetology, oncology, pain management, anti-infective
and pediatrics. Major markets include India, USA, Russia and CIS,
Germany, UK, Venezuela, S. Africa, Romania, and New Zealand. For more
information, log on to: www.drreddys.com
Lamictal® XR is a trademark of GlaxoSmithKline
*IMS
National Sales Perspectives: Retail and Non-Retail MAT April 2013
Copyright Business Wire 2013