Navigation Links
FDA Approves Onfi To Treat Severe Type of Seizures
Date:10/24/2011

SILVER SPRING, Md., Oct. 24, 2011 /PRNewswire-USNewswire/ -- On Oct. 21, the U.S. Food and Drug Administration approved Onfi tablets (clobazam) for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older. As Onfi is intended to treat a disease or condition that affects fewer than 200,000 people in the United States, it was granted orphan drug designation by the FDA.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

"Lennox-Gastaut syndrome is a severe form of epilepsy that causes debilitating seizures," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "This is a difficult condition to treat, and it will be helpful to have an additional treatment option."

Lennox-Gastaut syndrome usually begins before 4 years of age, and can be caused by a number of conditions, including brain malformations, severe head injuries, central nervous system infections, and inherited degenerative or metabolic conditions. In 30 to 35 percent of patients, no cause can be found. Patients commonly have frequent seizures of a wide variety, including tonic (stiffening of the body, upward deviation of the eyes, dilation of the pupils, and altered respiratory patterns), atonic (brief loss of muscle tone and consciousness, causing abrupt falls), atypical absence (staring spells), and myoclonic (sudden muscle jerks).

Most children with Lennox-Gastaut syndrome experience some degree of impaired intellectual functioning or information processing, as well as developmental delays and behavioral disturbances.

The effectiveness of Onfi, when added to ongoing seizure medication, was established in two multicenter controlled studies of patients 2 years of age and older. In each study, the drug was tested for the amount of reduction in
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. FDA Approves Longer Duration Efficacy and Safety for EUFLEXXA®
2. FDA Approves Label Update for PREZISTA® to Include 192-Week Data in HIV-1-Infected Adult Patients Starting Treatment
3. FDA Approves Ferriprox to Treat Patients with Excess Iron in the Body
4. FDA Approves Combination Therapy Juvisync
5. FDA Approves Cialis to Treat Benign Prostatic Hyperplasia
6. FDA Approves Remicade to Treat Ulcerative Colitis in Children Older Than 6 Years
7. FDA Approves Soliris for Rare Pediatric Blood Disorder
8. FDA Approves New Indications for Prolia® (Denosumab) for the Treatment of Bone Loss in Patients With Prostate or Breast Cancer Undergoing Hormone Ablation Therapy
9. FDA Approves Xalkori with Companion Diagnostic for a Type of Late-stage Lung Cancer
10. FDA Approves Firazyr To Treat Acute Attacks of Hereditary Angioedema
11. FDA Approves Adcetris to Treat Two Types of Lymphoma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/18/2014)... 18, 2014   MacPractice,s MacPractice MD MU ... EHR certification, which designates that the software is capable ... and Stage 2 Meaningful Use measures required to qualify ... (ARRA).  MacPractice MD MU version 5.0 was certified on ... Office of the National Coordinator-Authorized Certification Body (ONC-ACB) and ...
(Date:9/18/2014)... Sept. 18, 2014 This BCC Research report discusses the ... players, market growth and size, and opportunities for different devices ... through 2018. Patent analysis in the report focuses on technological ... Europe and Japan ... and discuss the global medical device technologies market. - Analyze ...
(Date:9/18/2014)... , Sept. 18, 2014  KIYATEC announced today ... Small Business Innovation Research (SBIR) Phase II Contract ... the 27 institutes and centers that comprise the ... of the two year award, KIYATEC will expand ... issues at the forefront of cancer therapy strategies: ...
Breaking Medicine Technology:MacPractice MD MU Achieves ONC HIT 2014 Edition Complete EHR Certification from ICSA Labs 2MacPractice MD MU Achieves ONC HIT 2014 Edition Complete EHR Certification from ICSA Labs 3MacPractice MD MU Achieves ONC HIT 2014 Edition Complete EHR Certification from ICSA Labs 4MacPractice MD MU Achieves ONC HIT 2014 Edition Complete EHR Certification from ICSA Labs 5Medical Devices: Technologies and Global Markets 2Medical Devices: Technologies and Global Markets 3Medical Devices: Technologies and Global Markets 4National Cancer Institute Awards KIYATEC Nearly $2M to Advance Predictive Cancer Diagnostics 2National Cancer Institute Awards KIYATEC Nearly $2M to Advance Predictive Cancer Diagnostics 3
... Streamline Health Solutions, Inc. (Nasdaq: STRM ... for hospitals, announced today that two of its clients, ... North Carolina, contracted with Streamline Health to implement new ... began the beta phase of integration earlier this year, ...
... July 28, 2011 Pacira Pharmaceuticals, Inc. (Nasdaq: ... financial results for the company,s second quarter ended June 30, ... Aug. 11, 2011. The Pacira management team will host a ... and upcoming developments on Thursday, Aug. 11, 2011 at 9 ...
Cached Medicine Technology:Streamline Health Announces Two Clients Have Contracted for Multiple Integrations to Their Epic Systems 2Streamline Health Announces Two Clients Have Contracted for Multiple Integrations to Their Epic Systems 3Streamline Health Announces Two Clients Have Contracted for Multiple Integrations to Their Epic Systems 4Pacira Pharmaceuticals, Inc. Announces Timing for Second Quarter 2011 Financial Results Webcast and Conference Call 2
(Date:9/19/2014)... in infertile land, and bear many beans that are ... most legumes have a symbiotic relationship with bacteria, called ... then supply the host plant with ammonia as a ... nodules in their roots. However, if too many root ... of the plants, because the energy cost of maintaining ...
(Date:9/19/2014)... Lifeinsuranceprices.info has released a new blog post announcing ... online. , Clients who smoke or use other ... quotes from multiple providers on a single website. Insurance ... Smoking will always influence life insurance prices, in a ... for life coverage and if they have health issues, ...
(Date:9/19/2014)... PA (PRWEB) September 19, 2014 InventHelp, ... its clients, an inventor from New York, has created an ... patient from inclement weather or smoke during transport. This ... snapped to a stretcher and remain in place until removed, ... for a more comfortable move with protection from irritating smoke ...
(Date:9/19/2014)... 19, 2014 Outsourcing services provider Profit By ... US IT conglomerate to provide HR outsourcing services in India. ... an exclusive partner and will act as a talent acquisition ... deploy over 120 personnel across 3 locations in India in ... , "This is a significant win for us and we ...
(Date:9/19/2014)... FL (PRWEB) September 19, 2014 Dr. ... introduced Therapeutic Periodontal Treatment to their Miami practice. ... Dr. Gallardo and Dr. Lamas are one of ... the ‘total health’ approach for diagnosing and treating periodontal ... of the most under-diagnosed and under-treated diseases in the ...
Breaking Medicine News(10 mins):Health News:Long-distance communication from leaves to roots 2Health News:Smokers Can Compare Term Life Insurance Quotes At Lifeinsuranceprices.info! 2Health News:InventHelp® Client Patents “Patient Protector” – Designed to Protect Patients During Transport 2Health News:Profit By RPO Bags huge RPO contract from US-based Implementation Partner 2Health News:Gallardo & Lamas Periodontics & Implant Dentistry Therapeutic Periodontal Treatment Shown to Improve Patient’s Overall Health 2Health News:Gallardo & Lamas Periodontics & Implant Dentistry Therapeutic Periodontal Treatment Shown to Improve Patient’s Overall Health 3
... study conducted by the researchers at New York University School ... Asian immigrants are carriers// of the hepatitis B virus. These ... But it is surprising to know that most of the ... people who are infected had no health insurance. The rate ...
... place on record the exemplary work of art by students from ... by Oman in the ‘Unite for children Unite against Aids’ campaign ... for Children Unite Against Aids’ campaign encompasses four major goals spread ... percentage of the young victims of HIV/Aids; to provide better services ...
... Health workers by the Ontario government, to beat a possible ... from critics // , who see this is politically motivated ... The opinion doing the rounds is that the kits ... ,According to health minister George Smitherman, 15,000 emergency kits will ...
... Exercising for at least for half an hour a day and ... serving of vegetables and fish, may be the key// to longevity ... Health Organization. ,According to the study, exercising just 30 ... cycling and even climbing the stairs are included in the tally, ...
... University have developed ,the first knee replacement shaped to ... the U.S. Food and Drug Administration, and will be ... ,Dr. Aaron G. Rosenberg and Dr. Richard A. Berger, ... who sought to address shape-related differences of a woman’s ...
... A systematic review of studies has revealed that surgery ... intrauterine medication for women experiencing heavy periods in reducing ... ,However, on subjective measures of effectiveness — satisfaction and ... (IUD) is as effective as surgery, the review found. ...
Cached Medicine News:Health News:East Asian Immigrants Bring Hepatitis to New York 2Health News:Shapelier Knee Replacements for Women 2Health News:Shapelier Knee Replacements for Women 3Health News:Shapelier Knee Replacements for Women 4Health News:Surgery or IUD for Heavy Periods 2Health News:Surgery or IUD for Heavy Periods 3
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: