Navigation Links
FDA Approves Lamictal®XR™ (Lamotrigine) for Conversion to Monotherapy for Treatment of Partial Seizures in Appropriate Patients
Date:4/25/2011

RESEARCH TRIANGLE PARK, N.C., April 25, 2011 /PRNewswire/ -- GlaxoSmithKline (GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved Lamictal® XR™ (lamotrigine) Extended-Release Tablets for conversion to monotherapy in patients 13 years and older with partial seizures taking one anti-epileptic drug. This is a new indication for Lamictal XR which is already approved as add-on treatment for partial seizures and primary generalized tonic-clonic seizures in patients in this age group. Safety and effectiveness of Lamictal XR have not been established as initial monotherapy or for simultaneous conversion to monotherapy from two or more concomitant AEDs.

"We are committed to providing new and effective treatment options for patients," said Atul Pande, MD, senior vice president, Neurosciences Medicines Development Center, GlaxoSmithKline.  "The approval of Lamictal XR for conversion to monotherapy will provide an additional therapeutic option for appropriate patients."  

The approval was based on data from study LAM30055, an international, multicenter, historical control study evaluating 300 mg/day and 250 mg/day of Lamictal XR for conversion to monotherapy in patients 13 years and older with partial seizures taking one anti-epileptic drug.   In 'conversion to monotherapy,' an additional anti-epileptic drug is added to a patient's existing anti-epileptic drug therapy regimen while the original therapy is gradually withdrawn. LAM30055 used a historical control based on a pooled analysis of previously conducted conversion to monotherapy studies.

Of the 226 patients treated with Lamictal XR, eight patients reported 10 treatment-emergent serious adverse events, including one serious adverse event of rash. Other serious adverse events were seizure related, trauma, neoplasm, upper gastrointestinal hemorrhage, pyrexia and respiratory failure. No de
'/>"/>

SOURCE GlaxoSmithKline
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. FDA Approves the First Vaccine to Prevent Meningococcal Disease in Infants and Toddlers
2. FDA Approves Actemra to Treat Rare Form of Juvenile Arthritis
3. FDA Approves New Medical Device for Form of Brain Cancer
4. FDA Approves the NovoTTF-100A System for the Treatment of Patients With Recurrent Glioblastoma Multiforme (GBM) Brain Tumors
5. FDA Approves Horizant To Treat Restless Legs Syndrome
6. FDA Approves New Treatment for Rare Form of Thyroid Cancer
7. FDA Approves Special Protocol Assessment for Phase 3 Trial of Polaris Groups Cancer Therapeutic, ADI-PEG 20, in the Treatment of Hepatocellular Carcinoma
8. FDA Approves Hyperopia Application for the MEL 80 Excimer Laser from Carl Zeiss Meditec
9. FDA Approves New Treatment for a Type of Late-Stage Skin Cancer
10. FDA Approves Zostavax Vaccine to Prevent Shingles in Individuals 50 to 59 Years of Age
11. FDA Approves Gadavist for Central Nervous System Scans
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/31/2014)... SAN DIEGO , July 31, 2014  Sorrento Therapeutics, ... death of Mr. Amar Singh , Chief Business Officer ... of apparent natural causes on July 30. "Sorrento ... dear friend and colleague. Our immediate thoughts go to Amar,s ... President and Chief Executive Officer. Mr. Singh ...
(Date:7/31/2014)... Diabetes Care®, Inc. (NASDAQ: TNDM ), a medical ... reported its financial results for the quarter ended June 30, ... 2014 to the same period of 2013: , Sales ... , t:slim Pump shipments grew 64 percent to 2,235 pumps ... June 30, 2014 to the same period of 2013: ...
(Date:7/31/2014)... July 31, 2014 Nektar Therapeutics (Nasdaq: ... quarter ended June 30, 2014. Cash and ... million as compared to $309.1 million at March 31, 2014."The ... Nektar as we look forward to significant milestones for a ... President and Chief Executive Officer of Nektar. "The first of ...
Breaking Medicine Technology:Sorrento Announces the Unexpected Death of its Chief Business Officer 2Tandem Diabetes Care Reports Second Quarter 2014 Financial Results 2Tandem Diabetes Care Reports Second Quarter 2014 Financial Results 3Tandem Diabetes Care Reports Second Quarter 2014 Financial Results 4Tandem Diabetes Care Reports Second Quarter 2014 Financial Results 5Tandem Diabetes Care Reports Second Quarter 2014 Financial Results 6Nektar Therapeutics Reports Financial Results for the Second Quarter of 2014 2Nektar Therapeutics Reports Financial Results for the Second Quarter of 2014 3Nektar Therapeutics Reports Financial Results for the Second Quarter of 2014 4Nektar Therapeutics Reports Financial Results for the Second Quarter of 2014 5Nektar Therapeutics Reports Financial Results for the Second Quarter of 2014 6Nektar Therapeutics Reports Financial Results for the Second Quarter of 2014 7Nektar Therapeutics Reports Financial Results for the Second Quarter of 2014 8Nektar Therapeutics Reports Financial Results for the Second Quarter of 2014 9Nektar Therapeutics Reports Financial Results for the Second Quarter of 2014 10Nektar Therapeutics Reports Financial Results for the Second Quarter of 2014 11Nektar Therapeutics Reports Financial Results for the Second Quarter of 2014 12Nektar Therapeutics Reports Financial Results for the Second Quarter of 2014 13Nektar Therapeutics Reports Financial Results for the Second Quarter of 2014 14
... The Oklahoma Bureau of Narcotics (OBN) is partnering ... owner/operator of the Energy-from-Waste facility in Tulsa to safely ... March 1, 2011, through the Safe Trip for Scripts ... disposal metal containers in police and sheriff department lobbies ...
... CryoLife, Inc. (NYSE: CRY ), a ... and vascular surgery, announced today its results for the second ... second quarter were a record $29.4 million compared to $29.3 ... first six months increased to a record of $59.6 million ...
Cached Medicine Technology:Narcotics Bureau Partners With Covanta Energy and the City of Tulsa for Safe Prescription Drug Disposal 2Narcotics Bureau Partners With Covanta Energy and the City of Tulsa for Safe Prescription Drug Disposal 3CryoLife Reports Record Revenues for the Second Quarter and First Six Months of 2011 2CryoLife Reports Record Revenues for the Second Quarter and First Six Months of 2011 3CryoLife Reports Record Revenues for the Second Quarter and First Six Months of 2011 4CryoLife Reports Record Revenues for the Second Quarter and First Six Months of 2011 5CryoLife Reports Record Revenues for the Second Quarter and First Six Months of 2011 6CryoLife Reports Record Revenues for the Second Quarter and First Six Months of 2011 7CryoLife Reports Record Revenues for the Second Quarter and First Six Months of 2011 8CryoLife Reports Record Revenues for the Second Quarter and First Six Months of 2011 9CryoLife Reports Record Revenues for the Second Quarter and First Six Months of 2011 10CryoLife Reports Record Revenues for the Second Quarter and First Six Months of 2011 11CryoLife Reports Record Revenues for the Second Quarter and First Six Months of 2011 12CryoLife Reports Record Revenues for the Second Quarter and First Six Months of 2011 13CryoLife Reports Record Revenues for the Second Quarter and First Six Months of 2011 14CryoLife Reports Record Revenues for the Second Quarter and First Six Months of 2011 15CryoLife Reports Record Revenues for the Second Quarter and First Six Months of 2011 16CryoLife Reports Record Revenues for the Second Quarter and First Six Months of 2011 17CryoLife Reports Record Revenues for the Second Quarter and First Six Months of 2011 18
(Date:7/31/2014)... AK (PRWEB) July 31, 2014 ... announced the hiring of new dentist Dr. Jonathan Oudin, ... Oudin had previously practiced in Barrow, Alaska, for three ... Center for Dentistry hired Dr. Oudin to help take ... Center for Dentistry to continue growing and serving the ...
(Date:7/31/2014)... July 31, 2014 (HealthDay News) -- With the World ... West African Ebola outbreak has risen to 729, ... Thursday issued a travel warning for,the region. The ... to the affected countries -- Guinea, Liberia and Sierra ... that Ebola is worsening in West Africa," CDC Director ...
(Date:7/31/2014)... of invasive lionfish causing fish poisoning may be unfounded. ... derbies and targeted fisheries may remain the best way ... to know for sure whether a lionfish is toxic: ... lionfish were first reported off the coast of Florida ... number ever since. They,re now found in marine habitats ...
(Date:7/31/2014)... Insight Accelerator Labs member PhysIQ (formerly ... of investment for $4.6 million to fund the continued ... signs. The company joined Insight Accelerator Labs in ... the help of Insight development teams. , ... the Accelerator,” says Steve McPhilliamy, Executive Director of Insight ...
(Date:7/31/2014)... July 31, 2014 Women in the ... charge of their financial future. The Independent Woman ... opened registration for 6 upcoming Los Angeles area events. ... women, and with input from Kim Kiyosaki, a successful ... Rising Time) who is passionate about women’s financial education. ...
Breaking Medicine News(10 mins):Health News:Dr. Jonathan Oudin to Join Alaska Center for Dentistry at Wasilla Location 2Health News:CDC Issues Travel Warning as West Africa Ebola Outbreak Worsens 2Health News:Invasive lionfish likely safe to eat after all 2Health News:Invasive lionfish likely safe to eat after all 3Health News:Insight Accelerator Labs Advances Member Toward Commercialization 2Health News:Insight Accelerator Labs Advances Member Toward Commercialization 3Health News:The Independent Woman to Offer Financial Workshops in the Los Angeles Area - Developed by Women for Women 2
... study says that people with low birth weight may ... diet and controlling their body weights. ,Diabetes affects ... blood glucose and impaired function of the insulin that ... risk factors for diabetes are obesity, physical inactivity, genetic ...
... Researchers from University of Liverpool had proposed that patients ... from medication. They say that it is advisable to ... ,Researchers of the study feel that early treatment in ... a better quality of life with epilepsy. They have ...
... suggested that obesity,in middle age increases the risk ... progressive,brain dysfunction that occurs most commonly late in,life. ... activities. ,The 27 year longitudinal study that ... data from a population of around 10276,males and ...
... interesting prospective study undertaken by the,researchers at Massachusetts General ... that ,higher intake of low-fat dairy may lower the ... type 2 diabetes, either the body does not produce,enough ... for the body to be able to use,sugar. Type ...
... patients with highly active antiretroviral treatment (HAART) needs ... says researchers from Belgium. ,Highly active antiretroviral ... HIV/AIDS patient’s life expectancy. This is especially helpful ... patients will have to have a full commitment ...
... procedure to do laproscopic esophagectomy on patients who suffers// ... esophagus. ,Currently to test the extent of damage ... called laproscopic esophagectomy. In this process the surgeons had ... the patients to insert fiber optic instruments to be ...
Cached Medicine News:
All welded construction for strength and durability. Choice of stainless steel or chrome plated models....
Ideal for surgical procedures, these portable stands fit into tight areas for easy instrument access. Easy placement over patient....
Fixed chair back and armrests, electric lift with 8" (20.3cm) stroke, foot pedal control, choice of upholstery colors. Optional features: 15 tilt mechanism and footrest, locking rotation, sliding arm...
... HPX Streak Retinoscope comes ... and provides 40% more ... scopes and maintains a ... greatly enhances illumination and ...
Medicine Products: