Content about GlaxoSmithKline

October 10, 2013

A subsidiary of Johnson & Johnson has acquired rights to an experimental drug for hepatitis C from GlaxoSmithKline.

TITUSVILLE, N.J. — A subsidiary of Johnson & Johnson has acquired rights to an experimental drug for hepatitis C from GlaxoSmithKline.

Janssen Pharmaceuticals announced that it had bought, for an undisclosed among, the drug GSK2336805 from GSK. The drug, which belongs to a class known as NS5a replication complex inhibitors, is currently in mid-stage development.

September 17, 2013

Stiefel has launched a new drug for treating acne, the company said on Tuesday.

NEW YORK — Stiefel has launched a new drug for treating acne, the company said Tuesday.

Stiefel, which is a subsidiary of British drug maker GlaxoSmithKline, announced the launch of Fabior (tazarotene) foam, which it called the only retinoid in a topical foam formulation for acne vulgaris in patients aged 12 and older.

The drug originally received Food and Drug Administration approval in May 2012.

September 12, 2013

While pertussis is often considered a childhood disease, a new study from GlaxoSmithKline indicates it's a lot more common among older adults than commonly reported.

NEW YORK — While pertussis is often considered a childhood disease, a new study from GlaxoSmithKline indicates it's a lot more common among older adults than commonly reported.

September 10, 2013

A new set of guidelines from the Food and Drug Administration could bring a generic version of a respiratory drug made by GlaxoSmithKline closer to reality.

NEW YORK — A new set of guidelines from the Food and Drug Administration could bring a generic version of a respiratory drug made by GlaxoSmithKline closer to reality.

The FDA guidelines, a set of non-binding recommendations released Monday, outline studies that manufacturers can conduct to determine equivalence between GSK's Advair Diskus (fluticasone propionate; salmeterol xinafoate) and generic versions.

September 10, 2013

GlaxoSmithKline has successfully navigated three proton-pump inhibitor switches and still manages to grow its base.

PITTSBURGH — GlaxoSmithKline has successfully navigated three proton-pump inhibitor switches and still manages to grow its base. GSK's latest innovation is the Tums Chewy Delights, a non-chalky soft chew. Available in Very Cherry and Smooth Peppermint, the new Tums offering will be merchandised in both a 32-count bag and six-count sticks.

 

September 9, 2013

Boehringer Ingelheim Consumer Health Care on Monday announced the introduction of Captain Zantac, the new face of the Zantac brand.

RIDGEFIELD, Conn. — Boehringer Ingelheim Consumer Health Care on Monday announced the introduction of Captain Zantac, the new face of the Zantac brand. Captain Zantac is part of a powerful new 360-degree brand equity campaign that includes national television advertising and other high-profile promotional materials in print, online and at retail, the supplier stated. 

September 4, 2013

A joint venture founded by GlaxoSmithKline and Pfizer focused on treatments for HIV has expanded its support of community organizations in the South.

RESEARCH TRIANGLE PARK, N.C. — A joint venture founded by GlaxoSmithKline and Pfizer focused on treatments for HIV has expanded its support of community organizations in the South.

August 29, 2013

The Food and Drug Administration has approved the latest drug in BD's Simplist line, the company said Thursday.

FRANKLIN LAKES, N.J. — The Food and Drug Administration has approved the latest drug in BD's Simplist line, the company said Thursday.

BD announced the approval of ondansetron injection in the 4 mg/2 mL strength, an injectable drug used to prevent nausea and vomiting after surgery. The drug is currently on the FDA's drug shortage list due to recent increases in demand and supply issues faced by other manufactures, BD said.

August 22, 2013

The Food and Drug Administration has approved a supplemental regulatory application from Mylan for a generic antidepressant that was subject last year to scrutiny by the agency amid reports of efficacy problems, Mylan said Thursday.

PITTSBURGH — The Food and Drug Administration has approved a supplemental regulatory application from Mylan for a generic antidepressant that was subject last year to scrutiny by the agency amid reports of efficacy problems, Mylan said Thursday.

The drug maker announced the approval of its supplemental abbreviated new drug application, or sANDA, for bupropion hydrochloride extended-release tablets in the 300-mg strength. The drug is a generic version of GlaxoSmithKline's Wellbutrin XL.

August 20, 2013

The Food and Drug Administration has approved a generic drug for depression made by Par Pharmaceutical, the drug maker said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a generic drug for depression made by Par Pharmaceutical Cos., the drug maker said Tuesday.

Par announced the approval of bupropion hydrochloride extended-release tablets in the 300-mg strength. The drug is a generic version of GlaxoSmithKline's Wellbutrin XL and is used to treat major depressive disorder. The company already markets the generic drug in the 150-mg strength.

August 19, 2013

The Food and Drug Administration has approved a vaccine made by GlaxoSmithKline that protects against four strains of the flu, the drug maker said.

LONDON — The Food and Drug Administration has approved a vaccine made by GlaxoSmithKline that protects against four strains of the flu, the drug maker said.

August 13, 2013

The Food and Drug Administration approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection that is manufactured by GlaxoSmithKline.

WASHINGTON — The U.S. Food and Drug Administration on Monday approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection that is manufactured by GlaxoSmithKline.

Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. It is a pill taken daily in combination with other antiretroviral drugs.

August 5, 2013

The Food and Drug Administration has approved for shipment the latest version of a GlaxoSmithKline flu vaccine, the drug maker said Monday.

PHILADELPHIA — The Food and Drug Administration has approved for shipment the latest version of a GlaxoSmithKline flu vaccine, the drug maker said Monday.

The FDA approved the Fluarix Quadrivalent (influenza virus vaccine) for the 2013-2014 season for shipment to Centers for Disease Control and Prevention distribution centers and healthcare providers. GSK said this would be the first season in which vaccines protecting against more than three strains will be available.

July 31, 2013

The Food and Drug Administration has approved a Perrigo generic drug for treating dermatitis, the company said Wednesday.

ALLEGAN, Mich. — The Food and Drug Administration has approved a Perrigo generic drug for treating dermatitis, the company said Wednesday.

Perrigo announced the FDA approval of fluticasone propionate lotion in the 0.05% strength. The drug is a generic version of Fougera Pharmaceuticals division PharmaDerm's Cutivate and is used to treat inflammatory and pruritic manifestations of atopic dermatitis in patients ages 1 year and older.

The drug has annual sales of about $19 million, according to Symphony Health Solutions.

 

July 24, 2013

Canadian regulators have approved two drugs made by GlaxoSmithKline for treating skin cancer.

MISSISSAUGA, Ontario — Canadian regulators have approved two drugs made by GlaxoSmithKline for treating skin cancer, GSK said Wednesday.

The drug maker announced Health Canada's approval of Tafinlar (dabrafenib mesylate) and Mekinist (trametinib) in patients with melanoma that can't be removed by surgery or has spread to other parts of the body.

July 23, 2013

A federal court has ruled that a Mylan lawsuit against GlaxoSmithKline over an antidepressant drug can go to trial.

PITTSBURGH — A federal court has ruled that a Mylan lawsuit against GlaxoSmithKline over an antidepressant drug can go to trial, Mylan said Tuesday.

Mylan alleges that GlaxoSmithKline breached a contract the two companies had made when it agreed to supply competing drug maker Apotex with paroxetine hydrochloride extended-release tablets, a generic version of Paxil CR. The Third Circuit Court of Appeals' ruling reversed a summary judgment dismissing Mylan's claim.

July 16, 2013

The Food and Drug Administration has approved a generic epilepsy and bipolar disorder drug made by Actavis, the drug maker said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic epilepsy and bipolar disorder drug made by Actavis, the drug maker said.

The generic drug maker announced that it had received FDA approval for lamotrigine orally disintegrating tablets in the 25-mg, 50-mg, 100-mg and 200-mg strengths, a generic version of GlaxoSmithKline's Lamictal ODT.

June 28, 2013

Park City Group on Friday named industry veteran Janet Carter Smith SVP market development, with responsibility for developing business solutions, consulting and expanding efforts in market development.

PARK CITY, Utah — Park City Group on Friday named industry veteran Janet Carter Smith SVP market development, with responsibility for developing business solutions, consulting and expanding efforts in market development.

June 27, 2013

Onco360 is joining the limited-distribution network for two newly approved cancer drugs made by GlaxoSmithKline, the specialty pharmacy company said.

NEW YORK — Onco360 is joining the limited-distribution network for two newly approved cancer drugs made by GlaxoSmithKline, the specialty pharmacy company said.

The New York-based company said it had been selected as a distributor of Tafinlar (dabrafenib) and Mekinist (trametinib). The drugs were approved as standalone therapies, not a combined therapy.

June 10, 2013

A 26-member joint panel comprising the Food and Drug Administration's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management advisory committees voted to support modifying or removing the risk evaluation and mitigation strategy protocol for GlaxoSmithKline's Type 2 diabetes drug Avandia (rosiglitazone).

Historically, the FDA has followed advisory committee votes when making a decision on the marketing of a drug even though it is not bound by them, but assuming the agency follows the panel's advice, it could mean a lot for the controversial drug and the way it's dispensed. But even if Avandia winds up on retail pharmacy shelves again, it faces a very different landscape from its heyday.

A 26-member joint panel comprising the Food and Drug Administration's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management advisory committees voted to support modifying or removing the risk evaluation and mitigation strategy protocol for GlaxoSmithKline's Type 2 diabetes drug Avandia (rosiglitazone).

June 7, 2013

A joint Food and Drug Administration expert panel voted to recommend keeping a controversial GlaxoSmithKline diabetes drug available for certain patients, GSK said.

PHILADELPHIA — A joint Food and Drug Administration expert panel voted to recommend keeping a controversial GlaxoSmithKline diabetes drug available for certain patients, GSK said.

May 30, 2013

There can't be too many tried-and-true, immediate-action calcium carbonate formulations among heartburn remedies, no matter how many proton-pump inhibitors dot that shelf's landscape. At least that's what Bayer Consumer is counting on with its line extension of Alka Seltzer Fruit Chews.

There can't be too many tried-and-true, immediate-action calcium carbonate formulations among heartburn remedies, no matter how many proton-pump inhibitors dot that shelf's landscape. At least that's what Bayer Consumer is counting on with its line extension of Alka Seltzer Fruit Chews.

May 30, 2013

GlaxoSmithKline Consumer Healthcare today released results from a new national survey of partial denture wearers revealing that while more than half of survey respondents (58%) report that it's important to them to maintain the health of their teeth — more so than their diet (46%) or skin (11%) — more than one third (36%) of respondents did not change any of their behaviors within the first year of wearing their partial denture.

PITTSBURGH — GlaxoSmithKline Consumer Healthcare today released results from a new national survey of partial denture wearers revealing that while over half of survey respondents (58%) report that it's important to them to maintain the health of their teeth — more so than their diet (46%) or skin (11%) — more than one third (36%) of respondents did not change any of their behaviors within the first year of wearing their partial denture.

May 29, 2013

British drug maker GlaxoSmithKline has acquired Swiss vaccine development company Okairos for $325 million, GSK said Wednesday.

LONDON — British drug maker GlaxoSmithKline has acquired Swiss vaccine development company Okairos for $325 million, GSK said Wednesday.

Privately owned Okairos develops technologies used to create vaccines, and GSK said it would use them in the development of the "next generation" of vaccines for preventing infections and for treatment of infections and diseases, saying it would allow the development of the "next generation.

May 10, 2013

The Food and Drug Administration has approved a new treatment for chronic obstructive pulmonary disease, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for chronic obstructive pulmonary disease, the agency said Friday.

The FDA announced the approval of Breo Ellipta (fluticasone furoate and vilanterol), a once-per-day inhaler made by GlaxoSmithKline and Theravance for long-term treatment of COPD, which includes chronic bronchitis and emphysema.