Content about Anticonvulsants

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 31, 2014

The Food and Drug Administration on Friday approved Topamax (topiramate) for prevention of migraine headaches in adolescents ages 12 years to 17 years.

SILVER SPRING, Md. — The Food and Drug Administration on Friday approved Topamax (topiramate) for prevention of migraine headaches in adolescents ages 12 years to 17 years. This is the first FDA approval of a drug for migraine prevention in this age group. 

The medication is taken on a daily basis to reduce the frequency of migraine headaches.

Topamax was first approved by the FDA in 1996 to prevent seizures. It was approved for migraine prevention in adults in 2004.

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.

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 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.

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.

 

July 1, 2013

The Food and Drug Administration has approved a drug made by Sunovion and Dainippon Sumitomo Pharma Co. for bipolar disorder, Sunovion said.

MARLBOROUGH, Mass. — The Food and Drug Administration has approved a drug made by Sunovion and Dainippon Sumitomo Pharma Co. for bipolar disorder, Sunovion said Monday.

The FDA has approved Latuda (lurasidone hydrochloride) for use either alone or combined with lithium or valproate in patients with bipolar depression. The drug was already approved for treating schizophrenia.

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.

December 28, 2012

Mylan on Friday announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its phenytoin chewable tablets USP in the 50 mg strength.

 PITTSBURGH — Mylan on Friday announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its phenytoin chewable tablets USP in the 50 mg strength.

The product is a generic version of Pfizer's Dilantin Chewable Tablets, which are indicated for the control of generalized tonic-clonic (i.e., grand mal) and complex partial (i.e., psychomotor, temporal lobe) seizures, and prevention and treatment of seizures occurring during or following neurosurgery.

August 14, 2012

Upsher-Smith Labs has finalized its purchase of a British company that makes drugs for central nervous system and inflammatory disorders, the former said Tuesday.

MAPLE GROVE, Minn. — Upsher-Smith Labs has finalized its purchase of a British company that makes drugs for central nervous system and inflammatory disorders, the former said Tuesday.

July 30, 2012

The Food and Drug Administration has approved Watson Pharmaceuticals’ Next Choice One Dose (levonorgestrel) tablets in the 1.5-mg strength.

SUPPLIER NEWS — The Food and Drug Administration has approved Watson Pharmaceuticals’ Next Choice One Dose (levonorgestrel) tablets in the 1.5-mg strength. The drug is an emergency contraceptive used to prevent pregnancy following unprotected sex or contraceptive failure. It is a generic version of Teva Women’s Health’s Plan B One-Step, which had sales of about $88 million during the 12-month period ended in March, according to IMS Health.


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 24, 2012

A district court ruled in favor of Pfizer and Northwestern University in a patent infringement case relating to Lyrica (pregabalin).

NEW YORK — A district court ruled in favor of Pfizer and Northwestern University in a patent infringement case relating to Lyrica (pregabalin).

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.