Issued: Friday 21 September 2007, Research Triangle Park, NC

 

GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for the new drug application (NDA) for Lamictal^®XR™ (lamotrigine) Extended-Release Tablets.

This decision does not affect the current formulation of Lamictal® (lamotrigine) Tablets, which remains an important treatment for many patients with epilepsy.

Lamictal XR is an investigational once-daily extended-release formulation. The current marketed immediate-release formulation of Lamictal is twice daily for most patients with epilepsy. GSK is committed to working with the FDA to address any questions they have and evaluate the best way forward.

Information about Lamictal

Prescription Lamictal Tablets are not for everyone. Most people who take Lamictal tolerate it well. Common side effects with Lamictal include dizziness, headache, blurred or double vision, lack of coordination, sleepiness, nausea, vomiting, insomnia, tremor, and rash. Lamictal may cause other side effects not listed here. If you develop any side effects or symptoms you are concerned about, or if you need more information, call your doctor.

Although most patients who develop a rash while receiving Lamictal have mild to moderate symptoms, some individuals may develop a serious skin reaction that requires hospitalization. Rarely, deaths have been reported. It is not possible to predict whether a mild rash will develop into a more serious one. These serious skin reactions are most likely to happen within the first eight weeks of treatment with Lamictal. Serious skin reactions occur more often in children than in adults.

Rashes may be more likely to occur if you: take Lamictal in combination with valproate (brand names are Depakene^® (valproic acid)* and Depakote^® (divalproex sodium)*), take a higher starting dose of Lamictal than your doctor prescribed, or increase your dose of Lamictal faster than prescribed.

Patients who experience any of the following with or without a skin rash, tell your doctor immediately: hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, or swelling of lips or tongue. These symptoms may be the first signs of a serious reaction. A doctor should evaluate the condition and determine if patients should continue taking Lamictal.

Serious blood problems or liver problems have been reported with Lamictal, so tell your doctor if you develop symptoms such as unusual bruising or bleeding, severe muscle pain, weakness, fatigue, yellowing of the eyes or skin, and/or frequent infections.

You should not take Lamictal if you had an allergic reaction to it in the past.

Patients should always check to ensure that they receive Lamictal. Some patients prescribed Lamictal have been given the wrong medicine in error. Taking the wrong medication can cause serious health problems. When patients are prescribed Lamictal, they should make sure that both they and their pharmacist can read it clearly. Patients should compare the tablets in the pill bottle to those pictured in the Patient Information leaflet that comes with their prescription.

*Depakene and Depakote are registered trademarks of Abbott Laboratories

About GlaxoSmithKline

Lamictal was developed and is marketed by GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For detailed company information, see GlaxoSmithKline's website: www.gsk.com.

Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under 'Risk Factors' in the 'Business Review' in the company's Annual Report on Form 20-F for 2006.

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