Content about Epilepsy

April 8, 2014

Sunovion Pharmaceuticals on Monday announced that Aptiom (eslicarbazepine acetate), a once-daily antiepileptic drug, is now available across the United States.

MARLBOROUGH, Mass. — Sunovion Pharmaceuticals on Monday announced that Aptiom (eslicarbazepine acetate), a once-daily antiepileptic drug, is now available across the United States.

The drug, which received approval from the Food and Drug Administration on Nov. 8, 2013, is a prescription medicine used with other medicines to treat partial-onset seizures. The drug is available in four table strengths: 200 mg, 400 mg, 600 mg and 800 mg; it can be taken whole or crushed, with food or without.

March 13, 2014

The epilepsy therapeutics market value in the eight major countries — the United States, Canada, France, Germany, Italy, Spain, the United Kingdom and Japan — will increase from $3.4 billion in 2012 to $4.5 billion by 2019, at a compound annual growth rate of 3.9%, according to a new report from business intelligence provider GBI Research.

NEW YORK — The epilepsy therapeutics market value in the eight major countries — the United States, Canada, France, Germany, Italy, Spain, the United Kingdom and Japan — will increase from $3.4 billion in 2012 to $4.5 billion by 2019, at a compound annual growth rate of 3.9%, according to a new report from business intelligence provider GBI Research.

March 12, 2014

Upsher-Smith has received approval from the Food and Drug Administration for Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile.

MAPLE GROVE, Minn. — Upsher-Smith has received approval from the Food and Drug Administration for Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile.

Qudexy XR will be available to patients in second quarter 2014.

March 5, 2014

Upsher-Smith Labs introduced a new educational program created for patients living with seizure clusters, as well as their families and friends.

MAPLE GROVE, Minn. — Upsher-Smith Labs on Monday introduced a new educational program created for patients living with seizure clusters, as well as their families and friends. The initiative — called Seizure Clusters Connect — uses traditional and social media to offer patients and their caregivers a community for learning and support.

January 2, 2014

Drug maker Eisai will make a new epilepsy drug available in the United States starting on Monday, the company said.

WOODCLIFF LAKE, N.J. — Drug maker Eisai will make a new epilepsy drug available in the United States starting on Monday, the company said Thursday.

December 9, 2013

An experimental drug under development by Upsher-Smith Labs for epilepsy is able to reduce seizures in patients with mild to moderate side effects, according to results of a late-stage clinical trial announced Monday.

MAPLE GROVE, Minn. — An experimental drug under development by Upsher-Smith Labs for epilepsy is able to reduce seizures in patients with mild to moderate side effects, according to results of a late-stage clinical trial announced Monday.

November 18, 2013

Drug maker Upsher-Smith Labs will present data from a late-stage trial of a drug for treating epilepsy, the company said Monday.

MAPLE GROVE, Minn. – Drug maker Upsher-Smith Labs will present data from a late-stage trial of a drug for treating epilepsy, the company said Monday.

November 15, 2013

The Food and Drug Administration has given orphan drug designation to an experimental treatment for a rare form of epilepsy.

LONDON — The Food and Drug Administration has given orphan drug designation to an experimental treatment for a rare form of epilepsy.

GW Pharmaceuticals said Friday that the FDA had granted the designation to Epidiolex for Dravet syndrome, a severe, drug-resistant form of epilepsy that begins in infancy. The drug is an oral liquid of a highly purified extract of cannabidiol, a non-psychoactive molecule derived from the cannabis plant.

November 8, 2013

The Food and Drug Administration has approved a new drug for treating epileptic seizures, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating epileptic seizures, the agency said Friday.

The FDA announced the approval of Aptiom (eslicarbazepine acetate), made by Sunovion Pharmaceuticals, as an add-on medication for seizures in adults. About 200,000 new cases of seizures and epilepsy occur in the United States each year, according to the FDA.

November 4, 2013

Drug maker UCB is seeking approval for one of its drugs as a standalone therapy for epilepsy.

ATLANTA — Drug maker UCB is seeking approval for one of its drugs as a stand-alone therapy for epilepsy.

The company said Monday that the Food and Drug Administration had accepted its regulatory approval application for Vimpat (lacosamide) for adult epilepsy patients with partial-onset seizures. The drug is already approved as an add-on therapy for partial-onset seizures in patients aged 17 and older.

October 29, 2013

The Food and Drug Administration has approved a drug made by Lundbeck for treating a form of epilepsy in children, the drug maker said.

DEERFIELD, Ill. — The Food and Drug Administration has approved a drug made by Lundbeck for treating a form of epilepsy in children, the drug maker said.

Lundbeck announced the approval of Sabril (vigabatrin) as an add-on therapy for refractory complex partial seizures in children ages 10 years and older who have not responded adequately to other treatments, as long as the benefit of treatment outweighs the risk of vision loss. The drug was already approved for treating the same condition in adults in 2009.

August 23, 2013

Indian drug maker Dr. Reddy's Labs has launched a generic treatment for epilepsy, the company said.

HYDERABAD, India — Indian drug maker Dr. Reddy's Labs has launched a generic treatment for epilepsy, the company said.

Dr. Reddy's announced the launch of divalproex sodium extended-release tablets in the 250-mg and 500-mg strengths, used to treat epileptic seizures. The 250-mg tablets are available in bottle count sizes of 100, while the 500-mg tablets are available in sizes of 100 and 500.

August 19, 2013

The Food and Drug Administration has approved a new epilepsy drug made by Supernus Pharmaceuticals, the company said.

ROCKVILLE, Md. — The Food and Drug Administration has approved a new epilepsy drug made by Supernus Pharmaceuticals, the company said Monday.

Supernus announced the approval of Trokendi XR, a once-daily, extended-release formulation of the drug topiramate. As part of the approval, the FDA granted Supernus a waiver for some of the requirements for studies of the drug in children and a deferral for submission of other post-marketing data due in 2019, followed by clinical assessments in 2025.

August 13, 2013

Lundbeck announced today that Onfi (clobazam) CIV will be available in scored tablet and oral suspension formulations beginning this week after the formulations were recently approved by the Food and Drug Administration.

DEERFIELD, Ill. — Lundbeck announced today that Onfi (clobazam) CIV will be available in scored tablet and oral suspension formulations beginning this week after the formulations were recently approved by the U.S. Food and Drug Administration. Onfi is a prescription medication originally approved by the FDA in 2011, and is used along with other medicines to treat seizures associated with Lennox-Gastaut syndrome (LGS) in adults and children 2 years of age or older. Onfi is an oral anti-epileptic drug (AED) of the benzodiazepine class, and is a 1,5 benzodiazepine.

July 16, 2013

The Food and Drug Administration has approved a generic epilepsy and bipolar disorder drug made by Actavis, the drug maker said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic epilepsy and bipolar disorder drug made by Actavis, the drug maker said.

The generic drug maker announced that it had received FDA approval for lamotrigine orally disintegrating tablets in the 25-mg, 50-mg, 100-mg and 200-mg strengths, a generic version of GlaxoSmithKline's Lamictal ODT.

July 1, 2013

Dr. Reddy's Labs has launched a generic drug for treating epilepsy, the company said.

HYDERABAD, India — Dr. Reddy's Labs has launched a generic drug for treating epilepsy, the company said.

The Indian generic drug maker announced the launch of lamotrigine extended-release tablets in the 25-mg, 50-mg, 100-mg, 200-mg and 300-mg strengths. The drug is being distributed in bottle sizes of 30.

Lamotrigine extended-release tablets are a generic version of GlaxoSmithKline's Lamictal XR, branded and generic versions of which had sales of $300.5 million during the 12-month period that ended in April, according to IMS Health.

 

May 6, 2013

Pregnant women should not use migraine-prevention medications containing valproate sodium due to a higher risk of decreased IQ scores in children, the Food and Drug Administration warned.

SILVER SPRING, Md. — Pregnant women should not use migraine-prevention medications containing valproate sodium due to a higher risk of decreased IQ scores in children, the Food and Drug Administration warned Monday.

In addition to being used to prevent migraines, valproate drugs are used for treating epilepsy and bipolar disorder and include related drugs such as divalproex sodium and valproic acid. Most are available in generic form as well as under brand names like AbbVie's Depacon and Depakote and others.

January 15, 2013

A maker of drugs for epilepsy has appointed a new executive.

ROCKVILLE, Md. — A maker of drugs for epilepsy has appointed a new executive.

Supernus Pharmaceuticals announced the appointment of Victor Vaughn as SVP sales, a position in which he will be responsible for leading all the company's sales activities.

January 10, 2013

The Food and Drug Administration has approved a generic epilepsy drug made by Wockhardt, the company said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic epilepsy drug made by Wockhardt, the company said.

Wockhardt, based in India, announced the approval of lamotrigine extended-release tablets in the 25-mg, 50-mg, 100-mg, 200-mg and 300-mg strengths.

The drug is a generic version of GlaxoSmithKline's Lamictal XR. The U.S. market for the drug is about $250 million, according to IMS Health.

January 3, 2013

Pfizer's generics division has launched an authorized generic drug for treating epilepsy.

PEAPACK, N.J. — Pfizer's generics division has launched an authorized generic drug for treating epilepsy.

Greenstone announced the introduction of phenytoin tablets in the 50-mg strength, an authorized generic version of Pfizer's Dilantin Infatabs.

Authorized generics are generic drugs marketed under their generic names at a reduced price, often through third-party companies under contract with the original drug's manufacturer.

October 22, 2012

The Food and Drug Administration has approved a new drug for epilepsy, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for epilepsy, the agency said Monday.

The FDA announced the approval of Eisai's Fycompa (perampanel) tablets to treat partial-onset seizures in patients ages 12 years and older. Partial seizures are the most common type seen in people with epilepsy, according to the FDA.

July 26, 2012

Qualitest Pharmaceuticals announced that it has received approval from the Food and Drug Administration for its generic version of an epilepsy treatment.

HUNTSVILLE, Ala. — Qualitest Pharmaceuticals announced that it has received approval from the Food and Drug Administration for its generic version of an epilepsy treatment.

The drug maker said its abbreviated new drug application for levetiracetam extended-release tablets, in the 500-mg and 750-mg strength, was approved. The drug is a generic version of UCB's Keppra XR.

Total combined sales for levetiracetam extended-release tablets were approximately $124.8 million for the 12 months ended in May, according to IMS Health data.

July 23, 2012

A drug made by Pfizer for treating pain disorders doesn't affect men's reproductive functions, according to a new post-approval clinical study.

NEW YORK — A drug made by Pfizer for treating pain disorders doesn't affect men's reproductive functions, according to a new post-approval clinical study.

The drug maker announced Monday the results of study A0081104 of Lyrica (pregabalin), which compared the drug with placebo in healthy males to assess its effects on sperm production. The phase-4 study was required by the Food and Drug Administration.

June 26, 2012

The Food and Drug Administration has given tentative approval to Supernus Pharmaceuticals for a drug to treat epilepsy, the company said Tuesday.

ROCKVILLE, Md. — The Food and Drug Administration has given tentative approval to Supernus Pharmaceuticals for a drug to treat epilepsy, the company said Tuesday.

Supernus announced the tentative approval was given to Trokendi XR (topiramate), a once-daily treatment for the seizure disorder. The company said final approval was conditioned on resolution of market exclusivity issues concerning certain pediatric populations.

May 2, 2012

The Food and Drug Administration has approved a generic drug for epilepsy made by Acella Pharmaceuticals, the company said Wednesday.

ATLANTA — The Food and Drug Administration has approved a generic drug for epilepsy made by Acella Pharmaceuticals, the company said Wednesday.

Acella announced the approval of gabapentin oral solution in the 250-mg-per-5-mL strength. The drug is a generic version of Parke Davis' Neurontin.