Content about Anticonvulsants

July 18, 2012

Mylan has settled a patent litigation suit filed by Somaxon Pharmaceutical concerning an insomnia drug, Mylan said.

PITTSBURGH — Mylan has settled a patent litigation suit filed by Somaxon Pharmaceutical concerning an insomnia drug, Mylan said.

The generic drug maker said that under the settlement, it would have the right to sell doxepin hydrochloride tablets in the 3-mg and 6-mg strengths starting in January 2020. The drug is a generic version of Somaxon's Silenor.

July 5, 2012

The Food and Drug Administration has approved Lupin Pharmaceuticals' generic version of a drug used to treat pain and seizure disorders.

BALTIMORE — The Food and Drug Administration has approved Lupin Pharmaceuticals' generic version of a drug used to treat pain and seizure disorders.

Lupin announced the approval of pregabalin capsules in the 25-mg, 50-mg, 75-mg, 100-mg, 150-mg, 200-mg, 225-mg and 300-mg strengths. The drug is used to treat fibromyalgia, partial-onset seizures in adults, neuropathic pain associated with diabetic peripheral neuropathy and post-herpetic neuralgia.

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.

June 21, 2012

The Food and Drug Administration has approved a new indication for a Pfizer drug.

NEW YORK — The Food and Drug Administration has approved a new indication for a Pfizer drug.

Lyrica (pregabalin) capsules CV now can be used for the management of neuropathic pain associated with spinal cord injury. The drug received a priority review designation for this new indication as more than 100,000 patients — approximately 40% of the 270,000 patients with spinal cord injury in the United States — suffer from this chronic, complex pain condition.

June 7, 2012

The Food and Drug Administration has approved a drug made by GlaxoSmithKline and XenoPort for treating pain associated with shingles.

NEW YORK — The Food and Drug Administration has approved a drug made by GlaxoSmithKline and XenoPort for treating pain associated with shingles.

The drug makers announced Thursday the approval of Horizant (gabapentin enacarbil) extended-release tablets for managing post-herpetic neuralgia. The drug already had FDA approval for treating restless legs syndrome. The approval entitles XenoPort to a $10 million milestone payment from GSK, according to a collaborative agreement between the two companies.

February 29, 2012

The Food and Drug Administration has approved a drug for epilepsy made by Hi-Tech Pharmacal, the drug maker said Wednesday.

AMITYVILLE, N.Y. — The Food and Drug Administration has approved a drug for epilepsy made by Hi-Tech Pharmacal, the drug maker said Wednesday.

Hi-Tech announced the approval of levetiracetam oral solution in the 100 mg-per-milliliter strength. The drug is a generic version of UCB Pharma's Keppra oral solution and is used to treat partial onset seizures in people ages 16 years and older.

Various versions of the drug had sales of $62 million in 2011, according to IMS Health. Hi-Tech said it plans to launch the drug in May.

January 12, 2012

Prasco Labs will act as the distributor for an authorized generic version of a Shire anticonvulsant drug, the company said Thursday.

CINCINNATI — Prasco Labs will act as the distributor for an authorized generic version of a Shire anticonvulsant drug, the company said Thursday.

Prasco announced that it had partnered with Shire to distribute carbamazepine extended-release capsules in the 100-mg, 200-mg and 300-mg strengths. The drug is an authorized generic version of Carbatrol, used to treat certain types of seizures and pain.

Authorized generics are branded drugs sold under their generic names at a reduced price.

January 3, 2012

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

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.

December 22, 2011

Amneal Pharmaceuticals has launched its generic version of a drug designed to treat seizures in adults and children with epilepsy.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has launched its generic version of a drug designed to treat seizures in adults and children with epilepsy.

The generic drug maker said it received approval from the Food and Drug Administration on Dec. 16 for felbamate oral suspension in the 600-mg/5-mL strength. The Amneal generic is available in two sizes, 8 fl. oz./240 mL and 16 fl. oz./473 mL. It is a generic version of Meda Pharmaceuticals' antiepileptic Felbatol.

October 24, 2011

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

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.

October 10, 2011

Depomed has launched a new drug for treating shingles, the drug maker said Monday.

MENLO PARK, Calif. — Depomed has launched a new drug for treating shingles, the drug maker said Monday.

The company announced the launch of Gralise (gabapentin) tablets, a once-daily treatment for postherpetic neuralgia, the pain that follows healing of the rash associated with shingles.

Gralise is a proprietary formulation of gabapentin that uses patented polymer technology that enables gradual release of the drug. Depomed said it is not interchangeable with other branded or generic gabapentin-based drugs.

 

October 4, 2011

Amneal last month launched its version of an epilepsy treatment.

BRIDGEWATER, N.J. — Amneal last month launched its version of an epilepsy treatment.

The drug maker said that felbamate tablets are available in 400-mg and 600-mg strengths, following approval from the Food and Drug Administration last month. The drug is the first-to-market generic equivalent of Meda Pharmaceuticals' Felbatol, Amneal said.

The Amneal generic is available in 90-count bottles in 400-mg strength and 90- and 180-count sizes in 600-mg strength, the company said.

Annual U.S. sales of Felbatol totaled $43.7 million, according to IMS Health data.

October 4, 2011

A wave of patent expirations over the next several years will open up a broad swath of drugs to generic competition, and India's Lupin Pharmaceuticals is looking to benefit, according to published reports.

NEW YORK — A wave of patent expirations over the next several years will open up a broad swath of drugs to generic competition, and India's Lupin Pharmaceuticals is looking to benefit, according to published reports.

The Wall Street Journal reported that the Mumbai-based company planned to launch 25 to 30 new generic drugs each year over the next couple of years.

October 4, 2011

Mylan must pay $77 million to four health insurers over allegations that it sought to control the market on ingredients used for two anti-anxiety medicines, according to published reports.

NEW YORK — Mylan may have to pay $77 million to four health insurers over allegations that it sought to control the market on ingredients used for two anti-anxiety medicines, according to published reports.

Bloomberg reported that the Supreme Court rejected the drug maker's appeal of a 2005 jury verdict in a case that involved antitrust allegations regarding the drugs lorazepam and clorazepate.

September 15, 2011

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

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.

August 10, 2011

The Food and Drug Administration has approved a generic drug for epilepsy.

PISCATAWAY, N.J. — The Food and Drug Administration has approved a generic drug for epilepsy.

Innopharma announced the FDA approval of levetiracetam injection. The drug is a generic version of UCB's Keppra.

Innopharma has a licensing agreement with X-GEN Pharmaceuticals for marketing and distribution of the drug.

July 29, 2011

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

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.

July 18, 2011

Upsher-Smith Labs has started a late-stage clinical trial of a drug for treating patients with a rare and severe form of epilepsy, the drug maker said Monday.

MAPLE GROVE, Minn. — Upsher-Smith Labs has started a late-stage clinical trial of a drug for treating patients with a rare and severe form of epilepsy, the drug maker said Monday.

June 20, 2011

A generic drug maker has been granted approval from the Food and Drug Administration to manufacture its version of a urinary tract infection treatment.

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.


May 23, 2011

The Food and Drug Administration has approved a generic drug for epilepsy made by Mylan.

PITTSBURGH — The Food and Drug Administration has approved a generic drug for epilepsy made by Mylan.

Mylan said Monday that the FDA had approved its divalproex sodium capsules in the 125-mg strength. The drug is a generic version of Abbott’s Depakote Sprinkle capsules and is used to treat certain types of epileptic seizures.

Divalproex sodium capsules had sales of about $89 million during the 12-month period ended in March, according to IMS Health.

April 26, 2011

The Food and Drug Administration has approved a new indication for an epilepsy drug made by GlaxoSmithKline, the drug maker said Monday.

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.

March 4, 2011

The Food and Drug Administration has approved a drug made by Eisai to treat a rare form of epilepsy, the drug maker said Friday.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a drug made by Eisai to treat a rare form of epilepsy, the drug maker said Friday.

The FDA approved Banzel (rufinamide) oral suspension for the treatment of seizures in children and adults with Lennox-Gastaut syndrome. The condition, also called LGS, affects 1% to 4% of children with epilepsy.

“This new formulation provides an option for patients who may prefer a liquid or find it difficult to take the medication in tablet form,” Eisai president and CEO Lonnel Coats said.

March 4, 2011

Pregnant mothers taking a common drug for treating epilepsy may be putting their babies at risk, according to a new report from the Food and Drug Administration.

SILVER SPRING, Md. — Pregnant mothers taking a common drug for treating epilepsy may be putting their babies at risk, according to a new report from the Food and Drug Administration.

The FDA said Friday that the drug topiramate could increase the risk for such birth defects as cleft palate and cleft lip when used by expectant mothers. Johnson & Johnson markets the drug under the name Topamax, and it is available in generic form.

February 28, 2011

The Food and Drug Administration has approved a treatment for shingles made by a subsidiary of generic drug maker Mylan.

PITTSBURGH — The Food and Drug Administration has approved a treatment for shingles made by a subsidiary of generic drug maker Mylan.

Mylan announced Monday the approval of Matrix Labs’ gabapentin capsules in the 100-mg, 300-mg and 400-mg strengths. The drug is used to treat postherpetic neuralgia, a painful complication of shingles.

Gabapentin capsules had sales of about $300 million in 2010, according to IMS Health.

February 4, 2011

Hi-Tech Pharmacal subsidiary ECR Pharmaceuticals has launched a drug for treating insomnia.

AMITYVILLE, N.Y. — Hi-Tech Pharmacal subsidiary ECR Pharmaceuticals has launched a drug for treating insomnia.

ECR announced Friday the launch of Zolpimist (zolpidem tartrate) oral spray. The drug comes in units that provide 60 metered sprays, administering 5-mg or 10-mg doses of the active ingredient. As a hypnotic agent, the drug is classified as a CIV controlled substance by the federal government.