Content about Neurology

December 2, 2011
ABC's 'Nightline' shadows three meth busts

ABC's "Nightline: Late Evening News" on Wednesday aired an exposé on Kentucky's methamphetamine problem, shadowing law enforcement as they made three arrests in a state that employs an electronic tracking system for the over-the-counter ingredient pseudoephedrine. The officers investigated sales made at Walgreens, CVS and Walmart.

NEW YORK — ABC's "Nightline: Late Evening News" on Wednesday aired an exposé on Kentucky's methamphetamine problem, shadowing law enforcement as they made three arrests in a state that employs an electronic tracking system for the over-the-counter ingredient pseudoephedrine. The officers investigated sales made at Walgreens, CVS and Walmart.

November 23, 2011
FDA approves first drug for insomnia with middle-of-night waking, difficulty returning to sleep

The Food and Drug Administration has approved the first drug for insomnia in which patients wake in the middle of the night and have trouble returning to sleep.

SILVER SPRING, Md. — The Food and Drug Administration has approved the first drug for insomnia in which patients wake in the middle of the night and have trouble returning to sleep.

November 11, 2011
Watson files for approval of generic dementia treatment

Watson Pharmaceuticals is challenging Swiss drug maker Novartis' patent on a drug used to treat dementia, Watson said.

PARSIPPANY, N.J. — Watson Pharmaceuticals is challenging three of Swiss drug maker Novartis' patents on a drug used to treat dementia, Watson said.

The company said subsidiary Watson Labs had filed for approval generic rivastigmine transdermal system patches in the 4.6-mg and 9.5-mg strengths, both designed to last for 24 hours, with the Food and Drug Administration. The patches are used to treat mild to moderate dementia associated with Alzheimer's or Parkinson's disease.

October 24, 2011
FDA approves drug for severe epilepsy

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 17, 2011
Lannett begins shipping three generic drugs

Lannett announced that it has begun shipping three generic drugs that recently were approved by the Food and Drug Administration.

PHILADELPHIA — Lannett announced that it has begun shipping three generic drugs that recently were approved by the Food and Drug Administration.

The generic drug maker said that it has shipped diethylpropion tablets in the 25-mg strength; phentermine hydrochloride capsules in the 37.5-mg strength and loxapine capsules in 5-mg, 10-mg, 25-mg and 50-mg strengths.

October 10, 2011
Depomed launches shingles drug

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 launches generic Felbatol

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
Insomnia treatment under consideration for Rx-to-OTC switch

Insomnnia may be the next big treatment regimen to make a switch from prescription-only to over the counter.

SAN DIEGO — Insomnnia may be the next big treatment regimen to make a switch from prescription-only to over the counter.

October 4, 2011
Report: Supreme Court rejects Mylan appeal

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 13, 2011
Survey: Meth use down, thanks to services like NPLEx

Methamphetamine use is down by 50%, even as use of illicit drugs continued to climb between 2008 and 2010, according to a national survey conducted by the Substance Abuse and Mental Health Services Administration that was released last week.

ROCKVILLE, Md. — Methamphetamine use is down by 50%, even as use of illicit drugs continued to climb between 2008 and 2010, according to a national survey conducted by the Substance Abuse and Mental Health Services Administration that was released last week.

The number of current methamphetamine users decreased from 731,000 people ages 12 years and older (0.3% of the population) in 2006  to 353,000 (0.1%) in 2010.

September 7, 2011
Safeway raises $10.4 million for Muscular Dystrophy Association

After ending its five-week fundraising campaign to benefit the Muscular Dystrophy Association's efforts to develop treatments and assist people coping with neuromuscular diseases, Safeway announced that its stores raised $10.4 million for the organization.

PLEASANTON, Calif. — After ending its five-week fundraising campaign to benefit the Muscular Dystrophy Association's efforts to develop treatments and assist people coping with neuromuscular diseases, Safeway announced that its stores raised $10.4 million for the organization.

The campaign, which ran from Aug. 1 through Labor Day, marked Safeway's 10th annual fundraising effort. Safeway has raised more than $58 million for muscular dystrophy charities.

August 30, 2011
Eisai drug shows 'significant' reduction in epileptic seizures

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. — 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.

August 19, 2011
Sagent launches neuromuscular disorder drug

Generic drug maker Sagent Pharmaceuticals has launched a new drug for neuromuscular disorders, the company said.

SCHAUMBURG, Ill. — Generic drug maker Sagent Pharmaceuticals has launched a new drug for neuromuscular disorders, the company said.

Sagent announced the launch of vecuronium bromide, an injectable drug used to treat myasthenia gravis and Eaton-Lambert syndrome. The disorders cause muscle weakness and fatigue.

The market for vecuronium bromide is about $10 million in the United States, according to IMS Health.

August 11, 2011
GSK, XenoPort file sNDA for Horizant

Drug makers GlaxoSmithKline and XenoPort are seeking expanded approval for their restless legs syndrome treatment.

LONDON — Drug makers GlaxoSmithKline and XenoPort are seeking expanded approval for their restless legs syndrome treatment.

The drug makers this week announced the submission of a supplemental new drug application to the Food and Drug Administration, requesting approval for Horizant (gabapentin enacarbil) extended-release tablets as a treatment for postherpetic neuralgia, a nerve pain that commonly is seen in patients with shingles. GSK submitted the sNDA on behalf of the two companies.

August 2, 2011
Safeway commences 10th annual MDA campaign

Safeway announced its 10th annual campaign to benefit the Muscular Dystrophy Association's efforts to develop treatments and assist people coping with neuromuscular diseases.

PLEASANTON, Calif. — Safeway announced its 10th annual campaign to benefit the Muscular Dystrophy Association's efforts to develop treatments and assist people coping with neuromuscular diseases.

July 18, 2011
Upsher-Smith commences late-stage trial for epilepsy treatment

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.

July 12, 2011
Nonprescription migraine med study to be presented at Headache Update Conference

PuraMed BioScience on Monday announced that headache researcher Roger Cady will be exhibiting a poster presentation of his independent clinical study of PuraMed's nonprescription migraine medication LipiGesic-M at the 2011 Headache Update Conference being held in Orlando, Fla., July 14 to 17.

SCHOFIELD, Wis. — PuraMed BioScience on Monday announced that headache researcher Roger Cady will be exhibiting a poster presentation of his independent clinical study of PuraMed's nonprescription migraine medication LipiGesic-M at the 2011 Headache Update Conference being held in Orlando, Fla., July 14 to 17.

June 7, 2011
Actavis granted final approval for generic Ambien CR

The Food and Drug Administration has given final approval to a generic drug for insomnia made by Actavis, the drug maker said Monday.

MORRISTOWN, N.J. — The Food and Drug Administration has given final approval to a generic drug for insomnia made by Actavis, the drug maker said Monday.

The FDA approved the company’s zolpidem tartrate extended-release tablets in the 12.5-mg strength. The drug, which is a Schedule IV controlled substance, is a generic version of Sanofi’s Ambien CR. Actavis was the first company to launch a generic version of the drug in the 6.25-mg strength in October 2010.

June 2, 2011
Mylan gets go-ahead for generic Effexor XR

The Food and Drug Administration has approved a generic drug for depression and anxiety made by Mylan, the drug maker said Thursday.

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

Mylan announced the approval of venlafaxine hydrochloride extended-release capsules in the 37.5-mg, 75-mg and 150-mg strengths.

The drug, used to treat major depressive disorder and social anxiety disorder, is a generic version of Effexor XR, made by Wyeth. Mylan is launching the drug under a licensing agreement it made with Wyeth before its purchase by Pfizer.

April 21, 2011
GSK, Valeant respond to CRL for ezogabine

GlaxoSmithKline and Valeant last week responded to the Food and Drug Administration's complete response letter for the companies' investigational anti-epileptic drug.

LONDON — GlaxoSmithKline and Valeant last week responded to the Food and Drug Administration's complete response letter for the companies' investigational anti-epileptic drug.

April 7, 2011
Shionogi launches Cuvposa, partners with Diplomat Specialty Pharmacy

A treatment made by Shionogi for chronic, severe drooling in children and teenagers with neurological conditions has become available, the drug maker said Thursday.

FLORHAM PARK, N.J. — A treatment made by Shionogi for chronic, severe drooling in children and teenagers with neurological conditions has become available, the drug maker said Thursday.

April 6, 2011
Shire files lawsuit against Watson over Adderall XR

British drug maker Shire has filed suit against Watson Pharmaceuticals and subsidiaries, alleging patent infringement in a case concerning a drug used to treat attention deficit hyperactivity disorder.

DUBLIN — British drug maker Shire has filed suit against Watson Pharmaceuticals and subsidiaries, alleging patent infringement in a case concerning a drug used to treat attention deficit hyperactivity disorder.

Shire announced Wednesday that it had filed the suit in the U.S. District Court for the Southern District of New York against Watson and several subsidiaries over their attempt to market a generic version of Adderall XR (amphetamine, dextroamphetamine mixed salts) and breach of contract.

March 18, 2011
PSE's Rx-only switch in Arkansas opens a new can of worms

The latest Arkansas proposition to control PSE sales may deliver the biggest blow to the over-the-counter accessibility argument, as it restricts sales to Arkansas residents who have a state-issued picture ID and who don’t look like they might be meth addicts. It also is no more fair or effective to have pharmacists decide who looks like a meth addict and who doesn't. Worse, the bill includes a provision that would allow the Arkansas Board of Pharmacy to color any OTC medicine with the same brush as PSE.

WHAT IT MEANS AND WHY IT’S IMPORTANT — The latest Arkansas proposition to control PSE sales may deliver the biggest blow to the over-the-counter accessibility argument, as it restricts sales to Arkansas residents who have a state-issued picture ID and who don’t look like they might be meth addicts. It also is no more fair or effective to have pharmacists decide who looks like a meth addict and who doesn't. Worse, the bill includes a provision that would allow the Arkansas Board of Pharmacy to color any OTC medicine with the same brush as PSE.

March 8, 2011
Merz offers Xeomin users financial assistance with new programs

GREENSBORO, N.C. — Merz Pharmaceuticals has created two programs to provide financial assistance to patients using its drug for cervical dystonia, the company said Tuesday.

The programs — the Xeomin patient co-payment program and the Xeomin patient assistance program — cover Xeomin (incobotulinumtoxinA), designed to decrease the severity of abnormal head positions and neck pains in patients with the disease, which causes muscle contractions resulting in repetitive movements and abnormal postures.

March 4, 2011
Eisai's Banzel OKed as epilepsy treatment

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.