Content about Gabapentin

October 17, 2012

The Food and Drug Administration has accepted a regulatory approval application for a drug for hot flashes from Depomed, the drug maker said.

MENLO PARK, Calif. — The Food and Drug Administration has accepted a regulatory approval application for a drug for hot flashes from Depomed, the drug maker said.

Depomed submitted its application to the FDA for Serada (gabapentin), an extended-release drug for hot flashes in menopausal women.

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 30, 2012

The Food and Drug Administration has approved Watson Pharmaceuticals’ Next Choice One Dose (levonorgestrel) tablets in the 1.5-mg strength.

SUPPLIER NEWS — The Food and Drug Administration has approved Watson Pharmaceuticals’ Next Choice One Dose (levonorgestrel) tablets in the 1.5-mg strength. The drug is an emergency contraceptive used to prevent pregnancy following unprotected sex or contraceptive failure. It is a generic version of Teva Women’s Health’s Plan B One-Step, which had sales of about $88 million during the 12-month period ended in March, according to IMS Health.


July 24, 2012

A district court ruled in favor of Pfizer and Northwestern University in a patent infringement case relating to Lyrica (pregabalin).

NEW YORK — A district court ruled in favor of Pfizer and Northwestern University in a patent infringement case relating to Lyrica (pregabalin).

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 2, 2012

The Food and Drug Administration has approved a generic drug for epilepsy made by Acella Pharmaceuticals, the company said Wednesday.

ATLANTA — The Food and Drug Administration has approved a generic drug for epilepsy made by Acella Pharmaceuticals, the company said Wednesday.

Acella announced the approval of gabapentin oral solution in the 250-mg-per-5-mL strength. The drug is a generic version of Parke Davis' Neurontin.

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.

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.

April 25, 2011

SUPPLIER NEWS — Hi-Tech Pharmacal announced the tentative approval by the Food and Drug Administration of levofloxacin oral solution in the 25-mg/mL strength, a generic antibiotic. Levofloxacin oral solution is a generic version of Johnson & Johnson’s Levaquin, which had sales of $6 million in 2010, according to IMS Health. Hi-Tech expected to receive final approval in June, when Johnson & Johnson’s patent expires.


April 7, 2011

The Food and Drug Administration has approved a drug made by GlaxoSmithKline and Xenoport for treating restless legs syndrome, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by GlaxoSmithKline and Xenoport for treating restless legs syndrome, the agency said Thursday.

The FDA approved Horizant (gabapentin enacarbil) as a once-daily treatment for moderate-to-severe RLS.

“People with restless legs syndrome can experience considerable distress from their symptoms,” FDA Division of Neurology Products director Russell Katz said. “Horizant provides significant help in treating these symptoms.”

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.

July 19, 2010

Drug maker Pfizer is suspending some clinical studies of a biotech drug for treating pain...

June 23, 2010

Reports of worsening conditions among patients has led drug maker Pfizer to suspend a clinical...

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...

February 17, 2010

The Food and Drug Administration has declined to approve a drug used to treat restless...

January 26, 2010

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