Content about Mood stabilizers

May 6, 2013
Pregnant women shouldn't use valproate drugs to prevent migraines, FDA warns

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
Supernus appoints Victor Vaughn as SVP sales

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
FDA approves Wockhardt epilepsy drug

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.

June 7, 2012
FDA approves GSK, XenoPort drug for shingles pain

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.

January 12, 2012
Prasco to distribute authorized generic drug for seizures, pain

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.

June 20, 2011
ReportersNotebook — Chain Pharmacy, 6/27/11

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
Mylan receives FDA approval for generic Depakote Sprinkle capsules

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
Lamictal XR receives FDA approval as monotherapy

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.

November 8, 2010
Upsher-Smith to extend epilepsy drug trial

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.

 

 

September 8, 2010
FDA approves expanded use of Saphris

Merck's supplemental drug applications for its atypical antipsychotic received approval from the Food and Drug...

WHITEHOUSE STATION, N.J. Merck's supplemental drug applications for its atypical antipsychotic received approval from the Food and Drug Administration, the drug maker said.

Saphris now is indicated for the treatment of schizophrenia in adults, as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, and as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, Merck said.

June 3, 2010
Mylan’s generic shingles treatment approved by FDA

The Food and Drug Administration has approved Mylan’s version of a drug for complications related...