Dr. Reddy’s Announces the Launch of Lamotrigine Extended-Release Tablets
HYDERABAD, India -- June 26, 2013
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.
WARNING: SERIOUS SKIN RASHES
See full prescribing information for complete boxed warning.
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
• coadministration with valproate
• exceeding recommended initial dose of lamotrigine extended-release tablets
• exceeding recommended dose escalation for lamotrigine extended-release
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)
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
Dr. Reddy’s Laboratories
Investors and Financial Analysts:
Kedar Upadhye, +91-40-66834297
Saunak Savla, +91-40-49002135
Milan Kalawadia (USA), +1 908-203-4931
S Rajan, +91-40-49002445
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