Content about Epilepsy

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.

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.

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.

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.

MAPLE GROVE, Minn. — Drug maker Upsher-Smith Labs will unveil updates to its educational website for healthcare providers who specialize in epilepsy at the American Academy of Neurology's annual meeting in New Orleans, the company said.

The website, Epilog.us, has been expanded to include question-and-answer videos and other content from healthcare professionals and academics, the company said. The AAN meeting ends Thursday.

PITTSBURGH — The Food and Drug Administration has approved a drug for epilepsy made by Mylan, the drug maker said.

The FDA approved Mylan's levetiracetam extended-release tablets in the 500-mg and 750-mg strengths.

The drug is a generic version of UCB's Keppra XR, used to treat partial onset seizures in epilepsy patients ages 16 years and older.

Various versions of the drug had sales of about $162.8 million during the 12-month period ended in September, according to IMS Health.

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

The FDA announced the approval of Onfi (clobazam) tablets, made by Catalent Pharma Solutions and Lundbeck, as an add-on treatment for seizures associated with Lennox-Gastaut syndrome in patients ages 2 years and older. The agency gave the drug orphan drug designation because the disease affects fewer than 200,000 people in the United States.

BALTIMORE — The Food and Drug Administration has approved a generic drug for epilepsy made by Lupin Pharmaceuticals, the drug maker said.

Lupin announced the approval and launch of levetiracetam extended-release tablets in the 500-mg and 750-mg strengths.

The drug is a generic version of UCB's Keppra XR, which had sales of about $161 million during the 12-month period ended in June, according to IMS Health.

WOODCLIFF LAKE, N.J. — A drug under late-stage clinical development by Eisai reduced the frequency of seizures in patients with epilepsy, according to trial results the drug maker presented Tuesday at the 2011 International Epilepsy Congress.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has asked Eisai to redo its regulatory application for a drug to treat epilepsy, Eisai said Friday.

The drug maker said the FDA issued a refusal to file letter in response to its application for perampanel, designed to treat partial-onset seizures in patients with epilepsy. In the letter, the FDA requested reformatting and reanalyses of some datasets, though Eisai said new studies probably were unnecessary.

SUPPLIER NEWS — A generic drug maker has been granted approval from the Food and Drug Administration to manufacture its version of a urinary tract infection treatment. Amneal Pharmaceuticals said that its nitrofurantoin oral suspension in the 25-mg/5-mL strength is the first-to-market generic version of Furadantin, made by Shionogi Pharma. Amneal will sell its generic in 8-oz. (230-mL) size bottles, the company said. Annual U.S. sales of nitrofurantoin oral suspension totaled $40 million for the year ended in January, according to IMS Health data.


RESEARCH TRIANGLE PARK, N.C. — The Food and Drug Administration has approved a new indication for an epilepsy drug made by GlaxoSmithKline, the drug maker said Monday.