Content about Postherpetic neuralgia

September 26, 2012

A drug maker is suing the Food and Drug Administration to force the agency to give a special designation to one of its drugs.

MENLO PARK, Calif. — A drug maker is suing the Food and Drug Administration to force the agency to give a special designation to one of its drugs.

Depomed announced that it had filed suit against the FDA in federal district court for the District of Columbia seeking an order that would require the agency to grant the drug Gralise (gabapentin) orphan drug exclusivity for the management of post-herpetic neuralgia. The disease, also known as PHN, is a condition causing prolonged pain in people who have had shingles, a complication of chickenpox.

July 23, 2012

A drug made by Pfizer for treating pain disorders doesn't affect men's reproductive functions, according to a new post-approval clinical study.

NEW YORK — A drug made by Pfizer for treating pain disorders doesn't affect men's reproductive functions, according to a new post-approval clinical study.

The drug maker announced Monday the results of study A0081104 of Lyrica (pregabalin), which compared the drug with placebo in healthy males to assess its effects on sperm production. The phase-4 study was required by the Food and Drug Administration.

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 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.

May 29, 2012

Generic drug maker Watson Pharmaceuticals has entered a settlement that will allow it to launch a generic patch used to treat post herpetic neuralgia, a pain disorder associated with shingles.

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals has entered a settlement that will allow it to launch a generic patch used to treat post herpetic neuralgia, a pain disorder associated with shingles.

Watson announced Tuesday a settlement through one of its subsidiaries with Endo Pharmaceuticals and Teikoku Seiyaku Co. over its generic version of Lidoderm (lidocaine) topical patch. Lidoderm had sales of $1.2 billion during the 12-month period ended in March 2012, according to IMS Health.

April 12, 2012

Generic drug maker Impax Labs is challenging the patent protection on a drug used to treat postherpetic neuralgia, the company said Thursday.

HAYWARD, Calif. — Generic drug maker Impax Labs is challenging the patent protection on a drug used to treat postherpetic neuralgia, the company said Thursday.

Impax announced that it had filed a regulatory approval application with the Food and Drug Administration for gabapentin tablets, a generic version of Depomed's Gralise, in the 300-mg and 600-mg strengths.

March 9, 2012

A Food and Drug Administration panel will meet Monday to discuss a class of drugs designed to treat chronic painful conditions that currently are under development and the safety issues possibly related to the drugs.

WASHINGTON — A Food and Drug Administration panel will meet Monday to discuss a class of drugs designed to treat chronic painful conditions that currently are under development and the safety issues possibly related to the drugs.

December 15, 2011

A Food and Drug Administration expert panel will review a drug made by NeurogesX as a potential treatment for pain associated with HIV.

SAM MATEO, Calif. — A Food and Drug Administration expert panel will review a drug made by NeurogesX as a potential treatment for pain associated with HIV.

NeurogesX said Thursday that the FDA Anesthetic and Analgesic Drug Products Advisory Committee would meet on Feb. 9, 2012, to review the patch drug Qutenza (capsaicin) as a treatment for pain associated with HIV-associated peripheral neuropathy, or HIV-PN.

The drug currently is approved for treating pain associated with postherpetic neuralgia.

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.

 

August 11, 2011

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.

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 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.

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.

June 3, 2010

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

March 21, 2010

A once-a-day formulation of a Pfizer drug potentially could capture half of the market for...

January 26, 2010

A topical treatment for post-herpetic neuralgia, more commonly known as shingles, has received an orphan...

January 18, 2010

Watson Pharmaceuticals has filed for regulatory approval of a generic version of a pain drug...