Content about GlaxoSmithKline

July 15, 2011

The Food and Drug Administration has approved a generic anticoagulant drug made by Dr. Reddy’s Labs and Alchemia.

HYDERABAD, India — The Food and Drug Administration has approved a generic anticoagulant drug made by Dr. Reddy’s Labs and Alchemia.

Dr. Reddy’s and Brisbane, Australia-based Alchemia announced the FDA approval of fondaparinux sodium injection in the 2.5 mg/0.5 mL, 5 mg/0.4 mL, 7.5 mg/0.6 mL and 10 mg/0.8 mL strengths. Alchemia owns the patents covering the process for synthesis of fondaparinux.

July 11, 2011

Generic drug maker Amneal has launched three new liquid drugs, the company said Monday.

BRIDGEWATER, N.J. — Generic drug maker Amneal has launched three new liquid drugs, the company said Monday.

July 11, 2011

The Food and Drug Administration has approved a vaccine for preventing tetanus, diphtheria and whooping cough in elderly patients.

SILVER SPRING, Md. — The Food and Drug Administration has approved a vaccine for preventing tetanus, diphtheria and whooping cough in elderly patients.

The FDA announced the approval of GlaxoSmithKline’s Boostrix, a single-dose booster shot described as the first vaccine approved for preventing all three diseases in patients ages 65 years and older.

July 11, 2011

Stiefel, a GlaxoSmithKline company, has expanded its Revaleskin family of products with its new Revaleskin Illuminesse Brightening Complex.

RESEARCH TRIANGLE PARK, N.C. — Stiefel, a GlaxoSmithKline company, has expanded its Revaleskin family of products with its new Revaleskin Illuminesse Brightening Complex.

Made with CoffeeBerry whole fruit extract, the anti-aging treatment is designed to provide antioxidants to neutralize against free radical damage caused by UV exposure, which can result in uneven skin tone, mild age spots and the loss of brightness and youthful luminosity of the skin. For maximum sun protection, the formula should be used in addition to sunscreen, not as a substitute. 

June 21, 2011

Watson subsidiary Watson Labs is seeking approval for a drug designed to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

PARSIPPANY, N.J. — Watson subsidiary Watson Labs is seeking approval for a drug designed to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

The company filed an abbreviated new drug application to market dutasteride capsules in the 0.5-mg strength. The drug is a generic version of Avodart, which is made by GlaxoSmithKline.

June 20, 2011


Good things come in three — like the three antacids that for the 52 weeks ended April 17 collectively generated more than $118 million in sales on top of the sales base they had established in the year-ago period.



Good things come in three — like the three antacids that for the 52 weeks ended April 17 collectively generated more than $118 million in sales on top of the sales base they had established in the year-ago period.


June 14, 2011

GlaxoSmithKline has garnered strong interest in its portfolio of legacy brands that were placed on the sales block earlier this year, according to a Reuters report published Tuesday. And that interest is likely to pick up in the coming months, GSK CEO Andrew Witty told reporters during a meeting of pharmaceutical industry executives.

BRUSSELS — GlaxoSmithKline has garnered strong interest in its portfolio of legacy brands that were placed on the sales block earlier this year, according to a Reuters report published Tuesday. And that interest is likely to pick up in the coming months, GSK CEO Andrew Witty told reporters during a meeting of pharmaceutical industry executives.

The interest is coming from both established consumer healthcare companies, as well as private equity houses, the report noted.

June 13, 2011

The Food and Drug Administration has approved a new drug for epilepsy made by GlaxoSmithKline and Valeant Pharmaceuticals International, the drug makers said Monday.

RESEARCH TRIANGLE PARK, N.C. — The Food and Drug Administration has approved a new drug for epilepsy made by GlaxoSmithKline and Valeant Pharmaceuticals International, the drug makers said Monday.

The FDA approved Potiga (ezogabine) tablets for the treatment of partial-onset seizures in patients ages 18 years and older.

June 10, 2011

A new strain of swine flu has emerged that appears somewhat resistant to flu drugs, according to published reports.

NEW YORK — A new strain of swine flu has emerged that appears somewhat resistant to flu drugs, according to published reports.

Reuters reported that scientists in Australia and Singapore had found a variant of the H1N1 flu that showed some resistance to Roche’s Tamiflu (oseltamivir phosphate) and GlaxoSmithKline’s Relenza (zanamivir), though drug maker BioCryst currently is developing a drug called peramivir, to which the strain was not resistant.

May 23, 2011


It’s not often a niche brand manufacturer attempts to resuscitate what has been for years a commoditized category. But that’s exactly what Meda Consumer Healthcare will be attempting to do with iron — establish a good/better/best proposition to a supplemented category best defined as mediocre.


It’s not often a niche brand manufacturer attempts to resuscitate what has been for years a commoditized category. But that’s exactly what Meda Consumer Healthcare will be attempting to do with iron — establish a good/better/best proposition to a supplemented category best defined as mediocre. For the 52 weeks ended April 16, mineral supplement sales were down 3.3% to $534 million across food, drug and mass (including Walmart), according to Nielsen Group data.


May 19, 2011

A controversial GlaxoSmithKline drug for treating Type 2 diabetes no longer will be available through retail pharmacies as of Nov. 18, the Food and Drug Administration announced Wednesday.

SILVER SPRING, Md. — A controversial GlaxoSmithKline drug for treating Type 2 diabetes no longer will be available through retail pharmacies as of Nov. 18, the Food and Drug Administration announced Wednesday.

May 11, 2011

Drug maker Perrigo has reached a licensing agreement with Nycomed US that will allow it to launch a generic treatment for dermatitis in 2012, the company said.

ALLEGAN, Mich. — Drug maker Perrigo has reached a licensing agreement with Nycomed US that will allow it to launch a generic treatment for dermatitis in 2012, the company said.

Perrigo said it agreed to settle all Hatch-Waxman litigation relating to its generic version of Cutivate (fluticasone) lotion with Nycomed, allowing it to launch under a licensing agreement in September 2012.

Cutivate is used to treat dermatitis in patients ages 1 year and older and had sales of about $50 million during the 12-month period ended in February, according to Wolters Kluwer.

April 27, 2011

OTC Perspectives magazine on Tuesday named its third annual list of "Top OTC/HBA Marketers of the Year."

VERONA, N.J. — OTC Perspectives magazine on Tuesday named its third annual list of "Top OTC/HBA Marketers of the Year."

Marketers of over-the-counter products and health-and-beauty aids will be honored at a celebratory luncheon on May 10 during the OTC/HBA National Conference.

April 26, 2011

The Food and Drug Administration has approved a new indication for an epilepsy drug made by GlaxoSmithKline, the drug maker said Monday.

RESEARCH TRIANGLE PARK, N.C. — The Food and Drug Administration has approved a new indication for an epilepsy drug made by GlaxoSmithKline, the drug maker said Monday.

April 21, 2011

Companies that make vaccines, drugs and diagnostic tests for influenza will become key stakeholders in the World Health Organization’s Global Influenza Surveillance Network under an agreement reached at the Open Ended Working Group that WHO coordinated to support global preparedness for a future influenza pandemic.

LONDON — Companies that make vaccines, drugs and diagnostic tests for influenza will become key stakeholders in the World Health Organization’s Global Influenza Surveillance Network under an agreement reached at the Open Ended Working Group that WHO coordinated to support global preparedness for a future influenza pandemic.

April 21, 2011

GlaxoSmithKline and Valeant last week responded to the Food and Drug Administration's complete response letter for the companies' investigational anti-epileptic drug.

LONDON — GlaxoSmithKline and Valeant last week responded to the Food and Drug Administration's complete response letter for the companies' investigational anti-epileptic drug.

April 15, 2011

Duh, winning! Because there are no losers in this. GlaxoSmithKline will be able to funnel its extensive marketing dollars into a stable of poised-to-explode brands, niche marketers can take those brands being sold and breathe fresh marketing life into them and retailers now benefit most of all because a greater portfolio of brands are being marketed with gusto.

WHAT IT MEANS AND WHY IT’S IMPORTANT — Duh, winning! Because there are no losers in this. GlaxoSmithKline will be able to funnel its extensive marketing dollars into a stable of poised-to-explode brands, niche marketers can take those brands being sold and breathe fresh marketing life into them and retailers now benefit most of all because a greater portfolio of brands are being marketed with gusto.

April 14, 2011

GlaxoSmithKline on Thursday identified the remaining noncore over-the-counter brands that it intends to divest as the company focuses its Consumer Healthcare business around a portfolio of fast-growing priority brands and emerging markets.

LONDON — GlaxoSmithKline on Thursday identified the remaining noncore over-the-counter brands that it intends to divest as the company focuses its Consumer Healthcare business around a portfolio of fast-growing priority brands and emerging markets.

GSK said it planned to contact companies interested in acquiring the brands over the next few weeks and expected to complete all divestitures by late 2011.

April 12, 2011

Darren Singer, a 25-year GlaxoSmithKline veteran, has been named Safeway's SVP pharmacy, health and wellness, the retailer announced.

PLEASANTON, Calif. — Darren Singer, a 25-year GlaxoSmithKline veteran, has been named Safeway's SVP pharmacy, health and wellness, the retailer announced.

Singer will be responsible for retail pharmacy operations, specialty care, pharmacy services, compliance, benefit management and managed care for Safeway. He will report to Safeway's merchandising president, Kelly Griffith.

April 12, 2011

A point-of-sale safety check may reduce the risk of patients unsafely receiving a drug for Type 2 diabetes that may increase their risk of heart attack, according to a new study conducted by pharmacy benefit manager Prime Therapeutics and scheduled for presentation at the 23rd annual meeting of the Academy of Managed Care Pharmacy in Minneapolis.

ST. PAUL, Minn. — A point-of-sale safety check may reduce the risk of patients unsafely receiving a drug for Type 2 diabetes that may increase their risk of heart attack, according to a new study conducted by pharmacy benefit manager Prime Therapeutics and scheduled for presentation at the 23rd annual meeting of the Academy of Managed Care Pharmacy in Minneapolis.

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.”

March 30, 2011

Dr. Reddy’s Labs will assume ownership of a penicillin manufacturing site in Bristol, Tenn., from GlaxoSmithKline.

HYDERABAD, India — Dr. Reddy’s Labs will assume ownership of a penicillin manufacturing site in Bristol, Tenn., from GlaxoSmithKline.

The generic drug maker said it completed the acquisition of the facility and related product portfolio, including Augmentin and Amoxil brands. GSK will retain the existing rights for the aforementioned brands outside the United States.

Further financial terms and conditions of the transaction are not being disclosed.

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.