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Recent News and Articles on the Keywords: new + epilepsy + approves  Related to the article below (Last Update: 8/4/2008)


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Generic Depakote for Epilepsy Approved
HealthNews, CA - Aug 1, 2008
Suffering from epilepsy and want to save money on your prescriptions? Ask for the generic version. Recently the FDA approved generic versions of Depakote ...
FDA Approves Depakote to Treat Epileptic Seizures, Migraine? eFluxMedia
First Generic Versions of Depakote Approved Washington Post
FDA Approves First Generic Version Of Abbott Seizure Drug dBTechno
TopNews - TheMedGuru
all 59 news articles »  ABT

dBTechno
Epilepsy Therapy Project President Joyce Cramer to Provide ...
MarketWatch - Jul 10, 2008
The full results of this case-controlled clinical study of 112000 patients who have been diagnosed and newly treated with FDA-approved AEDs is expected to ...
Epilepsy drugs may require strictest warning Boston Globe
FDA Revises Its Letter for Nonapproval of Drugs New York Times
Health Highlights: July 10, 2008 U.S. News & World Report
CNNMoney.com - BusinessWeek
all 281 news articles »  JNJ - GSK

TopNews
US approves generics of Abbott seizure drug
Reuters - Jul 29, 2008
... birth defects just as the brand version, which is prescribed for epilepsy. The drug is also approved to treat bipolar disorder and migraine headaches. ...
FDA OKs First Generic Depakote WebMD
FDA Okays Generic Divalproex Sodium (Depakote) MedPage Today
all 88 news articles »  ABT
China Biotech in Review: Company Profiles and Drug Advancement
Seeking Alpha, NY - Aug 3, 2008
Starting immediately, NovaMed will promote and distribute Depakine, an epilepsy drug that is the most widely prescribed anti-convulsant in China. ...
Roche-Genentech, New Jersey Economic Development Authority ...
BioRegion News, NY - Jul 28, 2008
None of that was known on April 12, 2007, when New Jersey?s Commerce, Economic Growth & Tourism Commission approved the BRRAG grant for Hoffmann-La Roche by ...DNA
Questcor to Present At the 2008 BMO Capital Markets Focus On ...
MarketWatch - Jul 31, 2008
In addition, Acthar is not indicated for, but is used in treating patients with infantile spasms ("IS"), a rare form of refractory childhood epilepsy, ...QCOR
Strength Grace: Down to business with Bonnie Grueninger ? there?ll ...
Java Journal, Missouri - Aug 1, 2008
They took a methodical approach to everything, and by the time Jamestown Riding School was approved and reborn as Jamestown New Horizons, they were ready to ...
Choosing One's Battles
RedOrbit, TX - Aug 3, 2008
Searle was accused of having suppressed the findings of studies it had sponsored that had shown that aspartame causes severe epileptic seizures in monkeys. ...

dBTechno
Epilepsy Drug May Increase Risk of Birth Defects
MedPage Today, NJ - Jul 21, 2008
The researchers expressed further concern about topiramate's use in pregnancy because it is also approved for preventing migraine, a more common condition ...
Topamax Linked to Cleft Palate, Other Birth Defects Newsinferno.com
all 66 news articles »

The Southern Ledger
Doctor talks about role after Katrina
Los Angeles Times, CA - Jul 21, 2008
She helped get landmark state legislation approved to protect the actions of doctors and nurses during disasters. "I thought I had suffered at times in my ...
New Orleans doctor's ordeal changes law Memphis Commercial Appeal
all 223 news articles »
Source: Google News

Levetiracetam: The Preclinical Profile of a New Class of Antiepileptic Drugs? -
H Klitgaard - Epilepsia, 2001 - Blackwell Synergy
... FDA approves new epilepsy drug. Rockville, Md: National Press Office; December 1,
1999. FDA Talk Paper T99-54. 5. Goddard GV, McIntyre DC, Lerch CK. ...

[CITATION] UCB Says EU Approves New Use of Epilepsy Drug
T Month, P Months

[PDF] News Center -
FDAA TOPAMAX, TTC Seizure - fda.gov
... September 4, 2001 New Treatment Option Approved for Lennox-Gastaut Syndrome, One
of Most Debilitating Forms of Epilepsy May 15, 2000 FDA Approves Slower Dose ...

[CITATION] Current Health Care Events
NED Approved - Drug Benefit Trends, 2000

[CITATION] FDA Approves Keppra for Juvenile Myoclonic Epilepsy Indication
T Month, P Months

[PDF] NEWS & NOTES
APACA Recommendation - Am Psychiatric Assoc
... APA Council Approves Recommendation ... number of publications concerning the treatment
of epilepsy and the ... Robert S. Garber, MD, Belle Mead, New Jersey; treasurer ...
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On the Occasion of the 80th Anniversary of the Founding of the ILAE -
FE Dreifuss - Epilepsia, 1989 - Blackwell Synergy
... The International Epilepsy Congress takes place every 2 years ... The General Assembly
approves the actions of the ... Committee of the League, appoints new members to ...

Bioequivalence in development of antiepileptic drugs -
KW Sommerville - Epilepsy Research, 2006 - Elsevier
... 505 (j) is for generic formulas and approves drugs based on ... and marketed for prophylaxis
of migraine and a new formulation for epilepsy with higher ...

Prospero Lambertini: miraculous cure of epilepsy and canonization of Vatican saints -
JC DeToledo, MB DeToledo, MR Lowe - Epilepsy and Behavior, 2002 - Elsevier
... Cite or Link Using DOI (Opens New Window) Copyright ... Table 1. Patron saints of epilepsy
and of epileptics. ... When Rome accepts and approves the documents regarding ...

Overview of treatment guidelines for epilepsy -
JM Stern - Current Treatment Options in Neurology, 2006 - Springer
... Clearly, the FDA approves of the use of generics for ... has produced two guidelines
regarding the new AEDs?one ... of newly diagnosed patients with epilepsy and one ...

Source: Google Scholar
 
 

Epilepsy, FDA approves new indication for Topamax as initial monotherapy

 
 
FDA ( Food and Drug Administration ) approved a new use for Topiramate ( Topamax ) as initial monotherapy in patients 10 years of age and older with partial-onset or primary generalized tonic-clonic seizures.

Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than two seizures in the three months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials.

"Anti-epilepsy medications, or neuromodulators, are selected based on seizure type; however, the specific seizure type may not always be obvious at the time of diagnosis," said Tracy Glauser, director of the Comprehensive Epilepsy Center at the Cincinnati Children’s Hospital. " A treatment like Topiramate, which provides coverage for both partial-onset and primarily generalized tonic-clonic seizures, offers doctors an option in situations where differentiating between these seizure types is difficult."

Epilepsy is characterized by seizures, which are abnormal electrical discharges in the brain that temporarily disrupt normal brain function. Seizures are classified as "generalized," originating in both sides of the brain simultaneously, or "partial-onset," starting in one area of the brain.

In a double-blind clinical trial, 470 patients with partial-onset or primary generalized tonic-clonic seizures were randomized to treatment with 50 mg or 400 mg/day of Topiramate. The primary efficacy assessment was a group comparison of time to first seizure during the double-blind phase of the study.

Comparison of the Kaplan-Meier survival curves of time to first seizure favored the 400 mg/day group over the 50mg/day group. The recommended dose for monotherapy in patients 10 years of age and older is 400 mg/day in two divided doses.

Approximately 58 percent of patients randomized to 400 mg/day achieved this maximal dose in the monotherapy controlled trial; the mean dose achieved in the trial was 275 mg/day.


Epilepsy is one of the most common neurological disorders, occurring in an estimated 2.7 million Americans. Each year in the United States, approximately 200,000 people are diagnosed with epilepsy for the first time.

As monotherapy, the most common side effects of Topamax ( in the 400 mg/day group and at a rate higher than the 50 mg/day group ) in adults were: paresthesia, weight decrease, somnolence, anorexia, dizziness, and difficulty with memory; and in children: weight decrease, upper respiratory tract infection, paresthesia, anorexia, diarrhea, and mood problems.

In addition, Topiramate has been associated with serious adverse events including: hyperchloremic, non-anion gap metabolic acidosis ( lowering of serum bicarbonate levels )—measurement of baseline and periodic serum bicarbonate levels is recommended; acute myopia and secondary angle closure glaucoma—patients should seek medical attention if they experience blurred vision or ocular pain; oligohidrosis and hyperthermia—occurs most often in hot weather and in children; cognitive/psychiatric side effects, including somnolence and fatigue, cognitive dysfunction, and psychiatric/behavioral disturbances; hyperammonemia with or without encephalopathy—associated with the concomitant use of valproic acid; and kidney stonespatients should maintain an adequate fluid intake to minimize the risk of renal stone formation.

In women taking combination oral contraceptives with Topiramate, a significant decrease in estrogen exposure has been shown at Topiramate doses 200 mg/day. The possibility of decreased contraceptive efficacy and increased breakthrough bleeding should be considered.

Source: Ortho-McNeil Neurologics, 2005
 
 
 
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