Content about GlaxoSmithKline

September 21, 2010

A U.S. District Court has blocked Canadian generic drug maker Apotex from selling generic versions...

PITTSBURGH A U.S. District Court has blocked Canadian generic drug maker Apotex from selling generic versions of an antidepressant drug.

 

Generic drug maker Mylan said Tuesday that it had obtained a temporary restraining order from the U.S. District Court for the District of New Jersey prohibiting Apotex from selling generic versions of the drug Paxil CR (paroxetine hydrochloride), an extended-release formulation of GlaxoSmithKline’s Paxil.

 

 

September 16, 2010

The Food and Drug Administration said Friday it had begun a safety review of Takeda’s...

SILVER SPRING, Md. The Food and Drug Administration said Friday it had begun a safety review of Takeda’s Type 2 diabetes treatment Actos (pioglitazone) after receiving five-year data from a 10-year study Takeda Pharmaceuticals North America is conducting on the drug showing that some patients taking it could be at risk for bladder cancer.

 

September 12, 2010

The Food and Drug Administration did not completely withdraw from the market a drug used...

PHILADELPHIA The Food and Drug Administration did not completely withdraw from the market a drug used to treat a dangerous low blood pressure condition, but merely proposed to do so as a “step in the regulatory process,” according to a document posted on the agency’s website Monday.

The agency said its proposal last month to withdraw approval for Shire’s drug ProAmatine (midodrine) did not represent the actual withdrawal of the drug from the market, while calling for more data on the drug to verify its clinical benefit.

 

September 8, 2010

NEW YORK British drug maker GlaxoSmithKline and biotech company Genmab have started a late-stage trial...

NEW YORK British drug maker GlaxoSmithKline and biotech company Genmab have started a late-stage trial of a biotech drug for treating cancer, the two companies said.

 

September 8, 2010

Hi-Tech Pharmacal had $40.4 million in sales during its fiscal first quarter ended July 31,...

AMITYVILLE, N.Y. Hi-Tech Pharmacal had $40.4 million in sales during its fiscal first quarter ended July 31, the generic drug maker said Thursday. The numbers amounted to a decrease of $3 million from the same period in 2009.

 

September 7, 2010

Swiss drug maker Lonza will help British drug maker GlaxoSmithKline manufacture five biotech drugs in...

LONDON Swiss drug maker Lonza will help British drug maker GlaxoSmithKline manufacture five biotech drugs in early- and mid-stage clinical trials, the two companies said Wednesday.

 

Lonza will manufacture clinical trial batches of the drugs, all monoclonal antibodies in phase-1 and phase-2 testing, and provide additional access to manufacturing capacity so GSK can fulfill future demands. The two companies said other details of the agreement remain confidential.

 

 

September 6, 2010

GlaxoSmithKline Consumer Healthcare on Tuesday named Stacy Wallace to the newly created role of VP...

PITTSBURGH GlaxoSmithKline Consumer Healthcare on Tuesday named Stacy Wallace to the newly created role of VP customer marketing and 360° Insights.

Under Wallace’s direction, the customer marketing and 360° Insights team will continue the development and execution of category visions and strategies in the area of health and wellness and in the creation of insight-led innovative and fully evaluated shopper marketing programs, the company stated.

August 30, 2010

The Food and Drug Administration has pushed back its review date for a drug made...

LONDON The Food and Drug Administration has pushed back its review date for a drug made by GlaxoSmithKline and Valeant Pharmaceuticals.

The FDA has not yet completed the review of the new drug application for ezogabine, a drug designed to treat epileptic adults with partial onset seizures, after a formal risk evaluation and mitigation strategy was submitted to the agency from GSK and Valeant, per its request.

The FDA is expected to review the application by Nov. 30.

August 25, 2010

Chip Ganassi Racing on Wednesday announced that GlaxoSmithKline’s Breathe Right brand will be placed on...

INDIANAPOLIS Chip Ganassi Racing on Wednesday announced that GlaxoSmithKline’s Breathe Right brand will be placed on the nose of the team’s Target Indy car this weekend during the Peak Antifreeze and Motor Oil Indy 300 Chicagoland Speedway races.

Additionally, on Aug. 28, race fans will have the opportunity to meet two-time and reigning IZOD IndyCar Series champion Dario Franchitti, driver of the Target Indy car, on-site at the Breathe Right Advanced tent where free product samples will be made available.

August 25, 2010

To help raise awareness around Commit Lozenge, which has been folded into the Nicorette franchise,...

PITTSBURGH To help raise awareness around Commit Lozenge, which has been folded into the Nicorette franchise, GlaxoSmithKline earlier this week introduced a new commercial to its “Nicorette Makes Quitting Suck Less” campaign, the company announced Wednesday.

PITTSBURGH To help raise awareness around Commit Lozenge, which has been folded into the Nicorette franchise, GlaxoSmithKline earlier this week introduced a new commercial to its “Nicorette Makes Quitting Suck Less” campaign, the company announced Wednesday.

August 18, 2010

The Food and Drug Administration has decided to expedite the review of an investigational drug...

August 16, 2010

The global market for vaccines grew to more than $20 billion last year, according to...

NEW YORK The global market for vaccines grew to more than $20 billion last year, according to a report by healthcare market research firm Kalorama Information.

 

The New York-based firm’s report, “Vaccines 2010: World Market Analysis, Key Players and Critical Trends in a Fast-Changing Industry,” indicated that the world market for preventative vaccines was $22.1 billion in 2009, compared with $19 billion in 2008.

 

 

August 15, 2010

The Food and Drug Administration may rescind its approval of a drug used to treat...

August 11, 2010

A Food and Drug Administration advisory committee has given a nod of approval to an...

August 9, 2010

Nabi Biopharmaceuticals will receive an $8 million payment from British drug maker GlaxoSmithKline following a...

August 2, 2010

Victory Pharma has finished acquiring virtually all the assets of MiddleBrook Pharmaceuticals, Victory said Tuesday....

August 1, 2010

The Food and Drug Administration has approved a generic injected drug made by Sagent Pharmaceuticals...

SCHAUMBURG, Ill. The Food and Drug Administration has approved a generic injected drug made by Sagent Pharmaceuticals for treating migraine attacks, Sagent said Monday.

 

The FDA approved Sagent’s sumatriptan succinate injection in the 6 mg per 0.5 milliliter strength. The drug is used to treat acute migraine attacks and cluster headache episodes.

 

 

Sumatriptan is a generic version of GlaxoSmithKline’s Imitrex. Injectable sumatriptan had $22 million in sales in 2009, according to IMS Health.

July 21, 2010

British drug maker GlaxoSmithKline is the latest company to join health policy research organization the...

July 20, 2010

Generic drug maker Caraco Pharmaceutical Labs has launched a generic antidepressant, Caraco said Wednesday....

DETROIT Generic drug maker Caraco Pharmaceutical Labs has launched a generic antidepressant, Caraco said Wednesday.

 

The drug maker announced the launch of bupropion hydrochloride extended-release tablets in the 150 mg and 200 mg strengths.

 

 

The drug is a generic version of GlaxoSmithKline’s Wellbutrin SR. Various versions of the drug have annual sales of $300 million, according to Caraco.

 

July 20, 2010

Actavis has received regulatory approval from the Food and Drug Administration for a generic antidepressant,...

MORRISTOWN, N.J. Actavis has received regulatory approval from the Food and Drug Administration for a generic antidepressant, the drug maker announced Wednesday.

Actavis said it immediately will begin distributing its bupropion HCl extended-release (SR) tablets in 100-mg and 200-mg strengths. The drug is the generic equivalent of GlaxoSmithKline's Wellbutrin SR. Actavis already has marketed generic Wellbutrin SR in the 150-mg strength. The drug maker received approval in March 2008.

July 18, 2010

Some stolen inhalers for patients with asthma and chronic obstructive pulmonary disease have turned up...

SILVER SPRING, Md. Some stolen inhalers for patients with asthma and chronic obstructive pulmonary disease have turned up in pharmacies, the Food and Drug Administration warned Friday.

Two lots of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol) were stolen from a warehouse near Richmond, Va., last August, with lot numbers 9ZP2255 – NDC 0173-0696-00 and 9ZP3325 – NDC 0173-0697-00. The inhalers recently found were the first from the stolen lots to turn up in commerce, the FDA said.

 

July 14, 2010

A joint advisory committee of the Food and Drug Administration has voted to recommend allowing...

July 13, 2010

The Food and Drug Administration has approved a generic arthritis treatment made by Mylan, the...

PITTSBURGH The Food and Drug Administration has approved a generic arthritis treatment made by Mylan, the drug maker said Wednesday.

 

The FDA approved nabumetone tablets, a treatment for osteoarthritis and rheumatoid arthritis, in the 500 mg and 750-mg strengths.

 

 

July 13, 2010

Teva Pharmaceuticals has launched a drug for treating migraine headaches, the generic drug maker said....

NORTH WALES, Pa. Teva Pharmaceuticals has launched a drug for treating migraine headaches, the generic drug maker said.

 

Teva announced the launch of naratriptan tablets in the 1 mg and 2.5-mg strengths. The tablets are a generic version of GlaxoSmithKline’s Amerge. The drug is used to treat acute migraine attacks in adults with or without visual disturbances preceding the attacks known as aura.

 

 

July 11, 2010

Regional retail pharmacy chain Kerr Drug has hired former GlaxoSmithKline and Johnson & Johnson executive...