Content about Neurology

June 7, 2011

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

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

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

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

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

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

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

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 1, 2011

Patients who take generic antidepressants will remain as adherent as those who take brand-name drugs to treat the condition, according to a new study.

ST. LOUIS — Patients who take generic antidepressants will remain as adherent as those who take brand-name drugs to treat the condition, according to a new study.

The study, conducted by Express Scripts and published in the Journal of Managed Care Pharmacy, found patients starting generic selective serotonin reuptake inhibitors and generic selective norepinephrine reuptake inhibitors had a discontinuation rate of 44.2%, compared with 46.8% among those on brand-name SSRIs and SNRIs.

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 25, 2011

Watson Labs is hoping to be the first to market a generic version of a popular drug for attention deficit hyperactivity disorder.

PHILADELPHIA — Watson Labs is hoping to be the first to market a generic version of a popular drug for attention deficit hyperactivity disorder.

British drug maker Shire announced Thursday that it had received notification that Watson filed for regulatory approval of a version of Adderall XR (dextroamphetamine and amphetamine) capsules with the Food and Drug Administration. Watson’s application contained a Paragraph IV certification, a legal assertion that the patent covering Adderall XR is invalid, unenforceable or won’t be infringed by Watson’s product.

February 23, 2011

Use of amphetamines could increase the risk of Parkinson’s disease, according to a new study.

ST. PAUL, Minn. — Use of amphetamines could increase the risk of Parkinson’s disease, according to a new study.

February 22, 2011

Generic drug maker Hi-Tech Pharmacal has received Food and Drug Administration approval for its version of a drug used to treat neurological disorders, the company said Tuesday.

AMITYVILLE, N.Y. — Generic drug maker Hi-Tech Pharmacal has received Food and Drug Administration approval for its version of a drug used to treat neurological disorders, the company said Tuesday.

Hi-Tech announced the approval of gabapentin oral solution in the 250 mg/5 mL strength, a generic version of Pfizer’s Neurontin oral solution.

The drug is used to treat postherpetic neuralgia and epilepsy. Neurontin had sales of $15 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.

February 4, 2011

Tennessee may be the next state to adopt an electronic tracking tool to enforce pseudoephedrine sales restrictions and combat methamphetamine production in real time.

NASHVILLE — Tennessee may be the next state to adopt an electronic tracking tool to enforce pseudoephedrine sales restrictions and combat methamphetamine production in real time.

January 31, 2011

Transcept announced Monday that the Food and Drug Administration has classified the drug maker's insomnia treatment as a complete class-2 response, and assigned the drug a Prescription Drug User Fee Act action date for this summer.

POINT RICHMOND, Calif. — Transcept announced Monday that the Food and Drug Administration has classified the drug maker's insomnia treatment as a complete class-2 response, and assigned the drug a Prescription Drug User Fee Act action date for this summer.

Transcept resubmitted its new drug application for Intermezzo (zolpidem tartrate) on Jan. 18 after receiving a complete response letter from the FDA in October 2009. The drug maker said for the completion of the NDA review, the FDA set the PDUFA action date for July 14.

January 18, 2011

Transcept Pharmaceuticals has resubmitted its regulatory application for a drug to treat insomnia to the Food and Drug Administration, following a previous denial of approval by the agency, the drug maker said Tuesday.

POINT RICHMOND, Calif. — Transcept Pharmaceuticals has resubmitted its regulatory application for a drug to treat insomnia to the Food and Drug Administration, following a previous denial of approval by the agency, the drug maker said Tuesday.

Transcept sent in its application for Intermezzo (zolpidem tartrate), a pill placed under the tongue for treating patients who awake in the middle of the night and have difficulty falling asleep again.

January 13, 2011

Nevada Sen. Sheila Leslie, D-Reno, is working with Carson City district attorney Neil Rombardo on introducing a bill to require a prescription for pseudoephedrine as a tool to cut down on illicit methamphetamine production, the Las Vegas Review-Journal reported Wednesday evening.

LAS VEGAS — Nevada Sen. Sheila Leslie, D-Reno, is working with Carson City district attorney Neil Rombardo on introducing a bill to require a prescription for pseudoephedrine as a tool to cut down on illicit methamphetamine production, the Las Vegas Review-Journal reported Wednesday evening.

January 5, 2011

BALTIMORE — If the government paid for drug cost incentives for Medicare patients with congestive heart failure, the program could recoup those costs and more by spending less on expensive hospitalizations for patients. 


That finding was one of several to emerge from research conducted by pharmacy students at the University of Maryland School of Pharmacy. The four students presented their findings on elderly drug adherence at the annual meeting of the Gerontology Society of America in New Orleans.

December 3, 2010

The forward-looking vision employed by Gov. Jay Nixon in exploring “next steps” in fighting methamphetamine abuse before even the last step has been put into place and enacted is, in a matter of speaking, extremely short-sighted. It doesn’t even make fiscal sense, because the National Precursor Log Exchange will do more to curb many of the costs associated with fighting meth addicts without conversely increasing the costs associated with fighting a cold. And truth be told, there are probably a lot more stuffy heads in Missouri than there are meth addicts.

WHAT IT MEANS AND WHY IT'S IMPORTANT — The forward-looking vision employed by Gov. Jay Nixon in exploring “next steps” in fighting methamphetamine abuse before even the last step has been put into place and enacted is, in a matter of speaking, extremely short-sighted. It doesn’t even make fiscal sense, because the National Precursor Log Exchange will do more to curb many of the costs associated with fighting meth addicts without conversely increasing the costs associated with fighting a cold.

November 8, 2010

Drug maker Upsher-Smith Labs will add an extension study to its late-stage clinical trial of...

MAPLE GROVE, Minn. Drug maker Upsher-Smith Labs will add an extension study to its late-stage clinical trial of a drug for treating epilepsy, the company said Tuesday.

 

Upsher-Smith announced an additional study for patients who completed the phase-3 “Prevail” trial of the drug USL255 (topiramate extended-release). The drug is designed to provide a once-daily dosage for adults with the disease.

 

 

October 18, 2010

The Food and Drug Administration has approved a drug for treating insomnia made by Actavis,...

MORRISTOWN, N.J. The Food and Drug Administration has approved a drug for treating insomnia made by Actavis, the generic drug maker said Monday.

 

Actavis announced the approval of zolpidem tartrate extended-release tablets in the 6.25-mg strength. The company has begun shipping the drug.

 

 

The drug is a generic version of Sanofi-Aventis’ Ambien CR, which had sales of around $129 million during the 12-month period ended in June, according to IMS Health.

 

October 17, 2010

A company that develops drugs for pain is hoping to get approval of one of...

SAN MATEO, Calif. A company that develops drugs for pain is hoping to get approval of one of its drugs for a pain condition associated with HIV.

September 30, 2010

Mylan has launched a generic version of a common antidepressant, the company said Friday....

PITTSBURGH Mylan has launched a generic version of a common antidepressant, the company said Friday.

 

Mylan announced the launch of bupropion hydrochloride extended-release tablets in the 150-mg and 300-mg strengths, a once-daily treatment for depression.

 

 

The drug is a generic version of GlaxoSmithKline’s Wellbutrin XL. Various versions of the drug had sales of around $752 million during the 12-month period ended in June, according to IMS Health.

 

September 15, 2010

Walgreens is teaming up with the Muscular Dystrophy Association to administer flu shots to those...

SALT LAKE CITY Walgreens is teaming up with the Muscular Dystrophy Association to administer flu shots to those who need them most, according to published reports.

The MDA is handing out vouchers for free flu shots at Walgreens to those affected by muscular dystrophy and related diseases, according to ABC4News in Salt Lake City.

Voucher requests can be submitted here.