Content about GlaxoSmithKline

March 24, 2011

The Food and Drug Administration has approved a generic treatment for shingles and genital herpes made by Actavis, the drug maker said Wednesday.

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic treatment for shingles and genital herpes made by Actavis, the drug maker said Wednesday.

The FDA approved Actavis’ valacyclovir hydrochloride tablets in the 500-mg and 1-g strengths.

The drug is a generic version of GlaxoSmithKline’s Valtrex. Branded and generic forms of the drug had sales of about $1.5 billion in 2010, according to IMS Health.

March 24, 2011

Four-in-5 menthol smokers would quit if the Food and Drug Administration banned mentholated cigarettes, according to a survey conducted this month with sponsorship from GlaxoSmithKline Consumer Healthcare.

PARSIPPANY, N.J. — Four-in-5 menthol smokers would quit if the Food and Drug Administration banned mentholated cigarettes, according to a survey conducted this month with sponsorship from GlaxoSmithKline Consumer Healthcare.

The survey found that smokers of menthol cigarettes — who are disproportionately African-American — feel “twice-addicted” to the menthol and the tobacco, while 74% of them said the menthol made inhalation easier, and 40% said menthol flavoring was the only reason they smoked.

March 24, 2011

GlaxoSmithKline withdrew all regulatory approval applications for a drug designed to cut men's risk of developing prostate cancer.

LONDON — GlaxoSmithKline withdrew all regulatory approval applications for a drug designed to cut men's risk of developing prostate cancer.

The drug maker announced it no longer would pursue global approval for Avodart (dutasteride) and would work with regulatory agencies to remove the indication from the product’s license.

March 22, 2011

Hi-Tech Pharmacal was granted final approval from the Food and Drug Administration for its treatment of duodenal ulcers.

AMITYVILLE, N.Y. — Hi-Tech Pharmacal was granted final approval from the Food and Drug Administration for its treatment of duodenal ulcers.

The drug maker said its abbreviated new drug application for ranitidine syrup in the 15-mg/mL strength was approved. Ranitidine syrup is a generic version of GlaxoSmithKline’s Zantac syrup, which garnered sales of $21 million for 12 months ended in December 2010, according to IMS sales data.

Hi-Tech currently has 13 products awaiting approval at the FDA, the company said.

March 18, 2011

With respect to the Type 2 diabetes drug Avandia, British drug maker GlaxoSmithKline has another medical study to worry about.

LONDON — With respect to the Type 2 diabetes drug Avandia, British drug maker GlaxoSmithKline has another medical study to worry about.

March 14, 2011

Members of the Consumer Healthcare Products Association last week elected Paul Sturman, president and general manager of Pfizer Consumer Healthcare, to chair the association’s board, the association announced Monday.

WASHINGTON — Members of the Consumer Healthcare Products Association last week elected Paul Sturman, president and general manager of Pfizer Consumer Healthcare, to chair the association’s board, the association announced Monday.

March 11, 2011

GlaxoSmithKline said it is establishing a dedicated team to support community pharmacists and other healthcare professionals.

RESEARCH TRIANGLE PARK, N.C. — GlaxoSmithKline said it is establishing a dedicated team to support community pharmacists and other healthcare professionals.

Effective March 28, GSK said its community pharmacy liaisons will provide information and tools to help community pharmacists communicate with their patients about chronic diseases and the appropriate use of medicines and vaccines.

March 11, 2011

A late-stage trial of a biologic treatment for Type 1 diabetes appears to have failed, according to results announced Friday.

CAMBRIDGE, Mass. — A late-stage trial of a biologic treatment for Type 1 diabetes appears to have failed, according to results announced Friday.

March 10, 2011

The Food and Drug Administration has approved a treatment for lupus made by GlaxoSmithKline and Human Genome Sciences, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for lupus made by GlaxoSmithKline and Human Genome Sciences, the agency said Wednesday.

The FDA approved Benlysta (belimumab), a treatment for systemic lupus erythematosus, the first new treatment for the autoimmune disease in 56 years.

March 1, 2011

Meda has launched a new cold sore treatment made by commercialization partner Medivir, Medivir said Tuesday.

HUDDINGE, Sweden — Meda has launched a new cold sore treatment made by commercialization partner Medivir, Medivir said Tuesday.

The Swedish drug maker launched Xerese (acyclovir and hydrocortisone), a topical combination product designed to treat recurrent herpes simplex labialis.

Medivir said the U.S. market for cold sore products is $230 million, and it expected the drug to be successful, given Meda’s presence in the U.S. market.

February 28, 2011

The Food and Drug Administration has approved a GlaxoSmithKline drug for a rare blood disorder, GSK said Friday.

PHILADELPHIA — The Food and Drug Administration has approved a GlaxoSmithKline drug for a rare blood disorder, GSK said Friday.

The drug maker announced the approval of Promacta (eltrombopag) for chronic immune thrombocytopenic purpura, or ITP, in patients who have not responded adequately to other therapies. Chronic ITP results in increased destruction of inadequate production of platelets in the blood, creating an increased risk of bruising and bleeding.

The FDA granted Promacta orphan drug designation in May 2008 and accelerated approval in November 2008.

February 23, 2011

Use of amphetamines could increase the risk of Parkinson’s disease, according to a new study.

ST. PAUL, Minn. — Use of amphetamines could increase the risk of Parkinson’s disease, according to a new study.

February 18, 2011

SUPPLIER NEWS — Drug maker Valeant Pharmaceuticals International has acquired U.S. and Canadian rights to certain formulations of a GlaxoSmithKline drug used to treat cold sores. Valeant acquired the rights to nonophthalmic topical formulations of Zovirax (acyclovir) from GSK for $300 million through its Canadian subsidiary, Biovail Labs.



February 14, 2011

GlaxoSmithKline has changed prescribing information on the labeling for one of its Type 2 diabetes drugs to reflect new restrictions on the drug’s use, the drug maker said.

PHILADELPHIA — GlaxoSmithKline has changed prescribing information on the labeling for one of its Type 2 diabetes drugs to reflect new restrictions on the drug’s use, the drug maker said.

GSK said it revised the labeling for Avandia (rosiglitazone) to take into account the risks of heart attacks and heart failure in patients taking the drug.

The FDA moved to restrict access to Avandia last year and required GSK to create a risk evaluation and mitigation strategy for the drug.

February 7, 2011

GlaxoSmithKline has received a license extension in Europe for its popular weight-loss pill Alli.

LONDON — GlaxoSmithKline has received a license extension in Europe for its popular weight-loss pill Alli.

The drug maker said it plans to sell new chewable tablets this spring, available at pharmacies throughout the United Kingdom.

Alli has been available in the United Kingdom since early 2009.

February 7, 2011

GlaxoSmithKline company Stiefel has made its popular acne wash formulations available for over-the-counter use.

RESEARCH TRIANGLE PARK, N.C. — GlaxoSmithKline company Stiefel has made its popular acne wash formulations available for over-the-counter use.

Stiefel will market two products that are indicated for the treatment of acne over the counter under the PanOxyl brand: PanOxyl acne creamy wash will be available in 4% BPO and 8% BPO.

A marketing campaign directed toward pharmacists and dermatologists will communicate details of the new PanOxyl 4% and 8% BPO acne creamy washes. The products will be available for shipment in May.

February 3, 2011

US WorldMeds has announced a new treatment for migraines, the drug maker said Wednesday.

LOUISVILLE, Ky. — US WorldMeds has announced a new treatment for migraines, the drug maker said Wednesday.

The company announced the launch of Alsuma auto-injector (sumatriptan), which injects the drug sumatriptan under the skin via a single-use, prefilled auto injector. The company is selling the drug under a licensing agreement from King Pharmaceuticals.

February 3, 2011

Drug maker Valeant Pharmaceuticals International has acquired U.S. and Canadian rights to certain formulations of a GlaxoSmithKline drug used to treat cold sores.

MISSISSAUGA, Ontario — Drug maker Valeant Pharmaceuticals International has acquired U.S. and Canadian rights to certain formulations of a GlaxoSmithKline drug used to treat cold sores.

Valeant announced Thursday that it had acquired the rights to nonophthalmic topical formulations of Zovirax (acyclovir) from GSK for $300 million through its Canadian subsidiary, Biovail Labs.

February 2, 2011

GlaxoSmithKline on Wednesday announced its support for the Wounded Warrior Project and Victory Junction, a camp for children with special needs, through its analgesic powder brands, BC and Goody’s.

MEMPHIS — GlaxoSmithKline on Wednesday announced its support for the Wounded Warrior Project and Victory Junction, a camp for children with special needs, through its analgesic powder brands, BC and Goody’s.

February 1, 2011

The Food and Drug Administration has turned down an application for an anti-obesity drug.

SAN DIEGO — The Food and Drug Administration has turned down an application for an anti-obesity drug.

Orexigen Therapeutics and Takeda Pharmaceutical said Tuesday that the FDA had issued a complete response letter for their application for Contrave (naltrexone hydrochloride and bupropion hydrochloride) extended-release tablets.

January 27, 2011

The Food and Drug Administration declined to approve a regulatory approval application from British drug maker GlaxoSmithKline concerning a cancer drug, GSK said Wednesday.

LONDON — The Food and Drug Administration declined to approve a regulatory approval application from British drug maker GlaxoSmithKline concerning a cancer drug, GSK said Wednesday.

GSK said the FDA issued a complete response letter for its application seeking approval for Avodart (dutasteride) to reduce the risk of prostate cancer in men at increased risk of developing the disease. The drug already is approved to treat enlarged prostate.

January 18, 2011

Colin Mackenzie has been appointed the new president of GlaxoSmithKline Consumer Healthcare North America. Mackenzie succeeds Roger Scarlett-Smith, who is relocating to London to become president of GSK Consumer Healthcare Europe.

PITTSBURGH — Colin Mackenzie has been appointed the new president of GlaxoSmithKline Consumer Healthcare North America. Mackenzie succeeds Roger Scarlett-Smith, who is relocating to London to become president of GSK Consumer Healthcare Europe.

Mackenzie has been directing the U.S. oral care business since 2007. Under the leadership of MacKenzie, the business accelerated its net sales growth rate, acquired the leading dry mouth product, Biotene, in 2008, and claimed the No. 1 toothpaste SKU in the United States (Sensodyne Extra Whitening).

January 17, 2011

Drug maker GlaxoSmithKline will take a legal charge of $3.4 billion related to its promotion of a controversial diabetes drug.

LONDON — Drug maker GlaxoSmithKline will take a legal charge of $3.4 billion related to its promotion of a controversial diabetes drug.

The British company said the charge related to an investigation by the U.S. Attorney’s Office for the District of Colorado regarding sales and promotion of the drug Avandia (rosiglitazone) in spite of reports of the risk of heart attacks in patients taking it.

January 5, 2011

WASHINGTON — The Consumer Healthcare Products Association recently named GlaxoSmithKline veteran Janet Carter-Smith chair of the CHPA Retailer Liaison Steering Committee effective Jan. 1. Carter-Smith is the third chair of this committee, succeeding David Howenstine, VP customer and industry development at Pfizer Consumer Healthcare, whose term ended at the end of the year.

January 4, 2011

Generic drug maker Par Pharmaceutical has begun shipping its version of a treatment for heart rhythm problems, the company said Monday.

WOODCLIFF LAKE, N.J. — Generic drug maker Par Pharmaceutical has begun shipping its version of a treatment for heart rhythm problems, the company said Monday.

Par announced the shipment of propafenone SR capsules, a treatment for atrial fibrillation in patients without structural heart disease.

The drug is a generic version of GlaxoSmithKline’s Rhythmol SR, which has annual sales of around $121 million, according to IMS Health.