Navigation Links
Keppra XR(TM) Extended-Release Tablets Filed with the FDA
Date:1/16/2008

U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for the use of Keppra XR(TM) (levetiracetam) in the adjunctive treatment of partial onset seizures in adults with epilepsy

ATLANTA, Jan. 16 /PRNewswire/ -- UCB announced today that the New Drug Application (NDA) for the use of Keppra XR(TM) (levetiracetam) extended- release tablets in the adjunctive treatment of partial onset seizures in adults with epilepsy has been accepted for filing by the U.S. Food and Drug Administration (FDA).

"This filing is another important step in the development of UCB's epilepsy franchise and demonstrates our commitment to bringing new and innovative therapies to the epilepsy community," said Iris Loew-Friedrich, MD, PhD, Global Head of Development, UCB Group. "There is an ongoing need for new antiepileptic drug options without the limitations of twice daily dosing. Epilepsy therapies with more convenient dosing schedules may help encourage greater patient compliance, which is important to effective seizure control."

The filing for Keppra XR(TM) is supported by a Phase III, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of extended-release levetiracetam tablets (2x500 mg) once-daily as adjunctive therapy in 158 refractory epilepsy patients, 12 to 70 years of age, with partial onset seizures.

The study met its primary endpoint for seizure reduction over placebo during the treatment period (p=0.038). The median percent reduction of partial onset seizures in the extended-release levetiracetam group was 46.1% compared to 33.4% with placebo during the 12 week treatment period. Additionally, 24.0% of patients randomized to the extended-release levetiracetam group had seizure frequency per week reduced by 75-100%, compared with 11.4% of patients in the placebo group. In the extended-release levetiracetam group 10.1% of patients had 100% reduction i
'/>"/>

SOURCE UCB
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. UCB Announces Positive Phase III Trial Results for Keppra XR(TM) (levetiracetam) Extended-Release Tablets
2. SEROQUEL XR(TM) Receives Approval From FDA for Maintenance Treatment of Schizophrenia
3. AstraZeneca Submits sNDAs for SEROQUEL XR(TM) for the Treatment of Bipolar Mania and Bipolar Depression
4. New Data Show Improvements in Work Performance in Patients with Chronic Insomnia Treated with AMBIEN CR(R) (zolpidem tartrate extended-release) Tablets CIV
5. Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
6. A Phase II, Randomized, Double Blind, Placebo-Controlled Dose-Escalating Study, Meets the Clinical Endpoints of MTR106 Tablets During the Treatment of Acute Migraine Attacks Without Aura in Females
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... Mass. , Jan. 15, 2014  Zafgen, Inc., ... unmet needs of severely obese patients, today announced ... beloranib, a selective inhibitor of methionine aminopeptidase 2 ... severe form of genetic obesity.  These results showed ...
(Date:1/14/2014)...  Luminex Corporation (Nasdaq: LMNX ) today announced that ... 2013 on Monday, February 3, 2014. A press release announcing ... trading. (Logo: http://photos.prnewswire.com/prnh/20100104/LUMINEXLOGO ) ... highlights and financial results for the fourth quarter and twelve ...
(Date:1/14/2014)... Dynamic Healthcare Services, Inc. ("DHS"), a portfolio company of GMH ... Medical Equipment, Inc. ("Progressive") of Clarion, PA ... were not disclosed. Progressive is a full ... of sleep, mobility, and respiratory products to customers in the ...
Breaking Medicine Technology:Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 2Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 3Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 4Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 2Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 3Dynamic Healthcare Services Completes Progressive Home Medical Equipment of Clarion, PA Investment 2Dynamic Healthcare Services Completes Progressive Home Medical Equipment of Clarion, PA Investment 3
... Solutions LLC today announced the launch of their ... a minimally invasive, Board Certified, OB/GYN surgeon Dr. ... improve patient and surgical team safety.  This proprietary device ... and reload sutures with an efficient, one-handed motion resulting ...
... (Nasdaq: BMRN ) announced today that the ... study (PKU-016) to evaluate the effects of Kuvan (sapropterin ...  BioMarin expects to report results in the first half ... will provide quantitative data regarding the neuropsychiatric effects of ...
Cached Medicine Technology:Equinox Surgical Solutions Launches Flagship Product, SutureAssist® 2BioMarin Initiates Phase 3b Study to Evaluate the Effects of Kuvan on Neurophychiatric Symptoms in Subjects with PKU 2BioMarin Initiates Phase 3b Study to Evaluate the Effects of Kuvan on Neurophychiatric Symptoms in Subjects with PKU 3
(Date:4/17/2014)... (April 17, 2014) Two recent papers by ... and colleagues may help scientists develop treatments or ... fever, Japanese encephalitis and other disease-causing flaviviruses. , ... and molecular genetics at the School of Medicine ... Hughes Medical Institute, and colleagues recently published articles ...
(Date:4/17/2014)... Jon McCullers, MD, was recently invited to submit ... Nature Reviews Microbiology , one of the world,s ... infectious disease specialist, and chair of the Department ... Science Center, analyzed the epidemiology and microbiology of ... as well as more recent 2009 novel H1N1 ...
(Date:4/17/2014)... April 17, 2014U.S. military personnel who served in ... concussive traumatic brain injury (TBI) were compared to ... other medical reasons. Differences in measures of overall ... months after injury are reported in an article ... journal from Mary Ann Liebert, Inc., publishers. The ...
(Date:4/17/2014)... that as many as 10 million older Americans suffer ... and isolation. , However, new research a project ... Americans for six years found that Internet use ... by more than 30 percent. , "That,s a very ... professor of telecommunication, information studies and media who led ...
(Date:4/17/2014)... CHICAGO, IL, April 17, 2014-- Colic affects about one ... accounts for numerous pediatric visits during the first several ... of colic symptoms was showing promise; however, the April ... (BMJ2014;348:g2107; Sung, Valerie) reported on a study, "Probiotics ... probiotic L reuteri for infant colic ...
Breaking Medicine News(10 mins):Health News:CU researchers discover target for treating dengue fever 2Health News:Long-term effects of battle-related 'blast plus impact' concussive TBI in US military 2Health News:Internet use can help ward off depression among elderly 2Health News:New study says probiotic use for infant colic is not effective in reducing symptoms 2
... that 2.5 percent of the United States population, or about ... found to be higher for children, non-Hispanic blacks, and males, ... having food allergies were 4.4 times higher than others in ... by the National Institutes of Health and appears in the ...
... percent) of 11- to 13-year-old babysitters know who to contact ... is sick or injured (96 percent) or poisoned (85 percent), ... Academy of Pediatrics (AAP) National Conference and Exhibition in San ... had left children unattended while babysitting, and 20 percent opened ...
... Serena Gordon HealthDay Reporter , FRIDAY, Oct. 1 ... be more likely to recommend healthy lifestyle habits to their ... of times a week and rarely hit the gym, according ... experienced doctors and those who felt they,d been well-trained to ...
... than two hours per week reduces the risk of developing ... to women of the same race who do not exercise, ... Results were presented at the Third AACR Conference on The ... 3, 2010. "People often want to know ...
... out of lung CT scans to improve treatment of ... has earned a physician-scientist at The University of Texas ... the National Institutes of Health. The award, one ... $1.5 million over five years to Thomas Guerrero, M.D., ...
... (CAD) is increasing, in both screening and diagnostic mammography, according ... of the American College of Radiology ( www.jacr.org ). CAD ... of density, mass or calcification on a digitized mammographic image ... Screening mammography is an X-ray exam of ...
Cached Medicine News:Health News:Children, males and blacks are at increased risk for food allergies 2Health News:Doctors' Health, Well-Being Affect Patient Counseling 2Health News:Doctors' Health, Well-Being Affect Patient Counseling 3Health News:Vigorous exercise reduces breast cancer risk in African-American women 2Health News:NIH award goes to UT MD Anderson imaging innovator Guerrero 2Health News:NIH award goes to UT MD Anderson imaging innovator Guerrero 3Health News:Computer-aided detection is increasingly being used in screening and diagnostic mammography 2
Curved shafts with fine pointed tips. Smooth handle with dull finish....
Delicate curved shafts with light crisscross serrations. Serrated handle with polished finish. Most popular size or model....
Delicate cross serrated lightly curved tips with serrated handle and polished finish. Most popular size or model....
Delicate lightly curved tips, 1 x 2 mouse style teeth. Serrated handle with polished finish....
Medicine Products: