HYDERABAD, India
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 include (5.1): |
|
|
• coadministration with valproate |
|
|
• exceeding recommended initial dose of lamotrigine extended-release tablets |
|
|
• exceeding recommended dose escalation for lamotrigine extended-release tablets |
|
|
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) |
|
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
CONTACT
Dr. Reddy’s Laboratories
Investors and Financial Analysts:
Kedar
Upadhye, +91-40-66834297
kedaru@drreddys.com
or
Saunak
Savla, +91-40-49002135
saunaks@drreddys.com
or
Milan
Kalawadia (USA), +1 908-203-4931
mkalawadia@drreddys.com
or
Media:
S
Rajan, +91-40-49002445
rajans@drreddys.com
