Content about Pharmacist Society

July 5, 2011

The Food and Drug Administration has approved a drug made by Novartis for treating chronic obstructive pulmonary disease, the FDA said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Novartis for treating chronic obstructive pulmonary disease, the FDA said Friday.

The FDA approved Arcapta Neohaler (indacaterol inhalation powder) for long-term, once-daily maintenance of bronchodilator treatment of airflow obstruction in people with COPD, including chronic bronchitis and emphysema.

COPD, which often results from cigarette smoking, is the fourth-leading cause of death in the United States, according to the Centers for Disease Control and Prevention.

July 5, 2011

As part of a strategic assessment, generic drug maker Par Pharmaceutical is set to restructure its branded division.

WOODCLIFF LAKE, N.J. — As part of a strategic assessment, generic drug maker Par Pharmaceutical is set to restructure its branded division.

The company said last week that its restructuring of Strativa Pharmaceuticals will result in a reduced workforce, prompting one-time noncash charges in the second quarter in addition to severance costs, although Par said the restructuring will generate expense savings in the $8 to $12 million range for the remainder of the year.

July 5, 2011

Pfizer defended a drug used for smoking cessation Monday following reports of a Canadian study that found it raised the risk of heart problems.

NEW YORK — Pfizer defended a drug used for smoking cessation Monday following reports of a Canadian study that found it raised the risk of heart problems.

The 8,216-patient study of Chantix (varenicline), published in the Canadian Medical Association Journal, found that of the 4,908 patients who received Chantix, 52 had an increased risk of serious heart problems, with similar risks appearing in 27-of-the-3,308 patients who took placebo.

July 5, 2011

ProPhase Labs on Tuesday announced that it received a letter from the NASDAQ Stock Market indicating that the company no longer is in compliance with NASDAQ listing rules because the closing bid price per share of its common stock has dropped below $1 per share for 30 consecutive trading days.

DOYLESTOWN, Pa. — ProPhase Labs on Tuesday announced that it received a letter from the NASDAQ Stock Market indicating that the company no longer is in compliance with NASDAQ listing rules because the closing bid price per share of its common stock has dropped below $1 per share for 30 consecutive trading days.

ProPhase will have until Dec. 27 to push its stock price above $1 for a minimum of 10 consecutive trading days to regain compliance or risk being delisted.

July 5, 2011

New graphic cigarette warning labels released last month by the Food and Drug Administration already appear to be having one desired effect: an increase in "quit smoking" queries to the national 1-800-QUIT-NOW smoking cessation line, the Associated Press reported Saturday.

ATLANTA — New graphic cigarette warning labels released last month by the Food and Drug Administration already appear to be having one desired effect: an increase in "quit smoking" queries to the national 1-800-QUIT-NOW smoking cessation line, the Associated Press reported Saturday.

The new labels aren’t even on cigarette packages yet — the labels will be implemented next year.

July 5, 2011

Sagent has received approval from the Food and Drug Administration for its antibacterial drug.

SCHAUMBURG, Ill. — Sagent has received approval from the Food and Drug Administration for its antibacterial drug.

The drug maker said that the FDA approved polymyxin B for injection USP. Sagent said that polymyxin B sulfate is used to treat infections of the urinary tract, meninges and bloodstream caused by susceptible strains of Pseudomonas aeruginosa.

The drug was developed in partnership with Strides Arcolab. Under the collaboration, Strides develops and supplies injectable products that Sagent will market in the United States.

July 5, 2011

Santal Solutions last week announced its dietary supplement Assurance Blood Health Support has gained distribution through Rite Aid and Walgreens.

NEENAH, Wis. — Santal Solutions last week announced its dietary supplement Assurance Blood Health Support has gained distribution through Rite Aid and Walgreens.

“We are excited that Assurance Blood Health Support is on the shelves of major retailers,” Santal president Dennis Torkko said. “This reinforces the strength of the product and provides an all-natural option for those individuals that are concerned about blood sugar, cholesterol and triglyceride levels.”

July 5, 2011

Shire has filed patent infringement suits against two generic drug makers relating to its attention deficit hyperactivity disorder treatment.

DUBLIN — Shire has filed patent infringement suits against two generic drug makers relating to its attention deficit hyperactivity disorder treatment.

Shire said it has filed lawsuits in the U.S. District Court for the District of New Jersey against Amneal Pharmaceuticals and Sandoz. Amneal and Sandoz recently filed abbreviated new drug applications with the Food and Drug Administration to market generic Vyvanse (lisdexamfetamine), an ADHD drug.

July 5, 2011

St. Joseph Aspirin has returned to store shelves with a series of product, packaging and retail enhancements, Ilex Consumer Products Group announced last month.

BALTIMORE — St. Joseph Aspirin has returned to store shelves with a series of product, packaging and retail enhancements, Ilex Consumer Products Group announced last month.

The new packaging will target baby boomers on a low-dose aspirin regimen, as recommended by doctors, to help lower the risk of heart attack and stroke. The new packaging copy calls out the need for the consumer to engage in an “Aspirin Regimen.”

July 5, 2011

Thomas Dowd has been named GNC EVP, chief merchandising officer and general manager, the company announced in a Securities and Exchange Commission filing Friday.

PITTSBURGH — Thomas Dowd has been named GNC EVP, chief merchandising officer and general manager, the company announced in a Securities and Exchange Commission filing Friday.

Dowd has served as EVP store operations and development since April 2007.

The move follows the announcement in June that Beth Kaplan would be stepping down from her role as GNC president and chief merchandising officer. Following that announcement, GNC CEO Joe Fortunato reassumed his role of president.

July 5, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating deep vein thrombosis in patients undergoing knee or hip replacement surgery, a J&J subsidiary said Friday.

RARITAN, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating deep vein thrombosis in patients undergoing knee or hip replacement surgery, a J&J subsidiary said Friday.

Janssen Pharmaceuticals announced the approval of Xarelto (rivaroxaban) tablets as a once-daily oral anticoagulant for DVT, a condition that could lead to pulmonary embolism.

June 30, 2011

Just about everybody seems satisfied with Diplomat Specialty Pharmacy’s services, according to the company’s 2011 patient satisfaction survey.

FLINT, Mich. — Just about everybody seems satisfied with Diplomat Specialty Pharmacy’s services, according to the company’s 2011 patient satisfaction survey.

Diplomat mailed the survey to 1,545 customers in May, of whom 463 responded. Of those respondents, 90% said Diplomat exceeded their expectations; 98% said it met their expectations; and 99% said they were satisfied overall with the specialty pharmacy provider.

Diplomat president and CEO Phil Hagerman said the results affirmed the provider’s patient-focused model.

June 30, 2011

Impax Labs has agreed not to market a generic version of a drug designed to reduce blood sugar and cholesterol in tablet form until 2015.

HAYWARD, Calif. — Impax Labs has agreed not to market a generic version of a drug designed to reduce blood sugar and cholesterol in tablet form until 2015.

June 30, 2011

Lichi Super Fruit is adding a meal replacement product to its lineup.

NEW YORK — Lichi Super Fruit is adding a meal replacement product to its lineup.

New Lichi Super Fruit Chocolate Delight Meal Replacement is a nutritious blend of natural cocoa, whey and soy proteins, vitamins and omega fatty acids that promotes weight loss and lean muscles, according to the company. The weight-management chocolate shake, which comes in a one-month supply, is set to hit select retail shelves in July.

Lichi Super Fruit Chocolate Delight Meal Replacement will be available for a suggested retail price of $24.99.

June 30, 2011

Innovation took center stage Thursday as Eli Lilly laid out its future growth strategies at a meeting with investors.

NEW YORK — Innovation took center stage Thursday as Eli Lilly laid out its future growth strategies at a meeting with investors.

At its “Bridging to the Future” meeting, Lilly said it had 70 drugs in its research and development pipeline, including 33 in phases 2 and 3. The company said it expects at least 10 new drugs to enter phase 3 this year, including drugs in such areas as cancer, diabetes and neuroscience, as well as new therapeutic areas, such as autoimmune disorders.

June 30, 2011

As part of this year's National Association of Chain Drug Stores Marketplace Conference in Boston, which came to a close Tuesday, NACDS conference exhibitors and Conventions C.A.R.E. dispersed 6.5 tons of consumer goods to various charitable organizations throughout the Greater Boston community.

ALEXANDRIA, Va. — As part of this year's National Association of Chain Drug Stores Marketplace Conference in Boston, which came to a close Tuesday, NACDS conference exhibitors and Conventions C.A.R.E. dispersed 6.5 tons of consumer goods to various charitable organizations throughout the Greater Boston community.

June 30, 2011

Amid ongoing economic challenges and a continued debate about the best uses of healthcare dollars in private and public healthcare plans, the National Association of Chain Drug Stores on Wednesday called for a renewed focus on the value of community pharmacy.

ALEXANDRIA, Va. — Amid ongoing economic challenges and a continued debate about the best uses of healthcare dollars in private and public healthcare plans, the National Association of Chain Drug Stores on Wednesday called for a renewed focus on the value of community pharmacy.

June 30, 2011

The National Advertising Division of the Council of Better Business Bureaus earlier this month determined that Rexall Sundown has supported claims regarding the company’s Osteo Bi-Flex glucosamine HCL and vitamin D3 dietary supplement.

NEW YORK — The National Advertising Division of the Council of Better Business Bureaus earlier this month determined that Rexall Sundown has supported claims regarding the company’s Osteo Bi-Flex glucosamine HCL and vitamin D3 dietary supplement.

June 30, 2011

Perrigo on Wednesday announced that its closing date to complete the acquisition of Paddock Labs — a generic pharmaceutical and specialty over-the-counter products manufacturer — has been delayed by an extended Federal Trade Commission review.

ALLEGAN, Mich. — Perrigo on Wednesday announced that its closing date to complete the acquisition of Paddock Labs — a generic pharmaceutical and specialty over-the-counter products manufacturer — has been delayed by an extended Federal Trade Commission review.

June 30, 2011

A group of physicians is urging the Food and Drug Administration not to approve a drug made by Gilead Sciences for the prevention of HIV infection.

LOS ANGELES — A group of physicians is urging the Food and Drug Administration not to approve a drug made by Gilead Sciences for the prevention of HIV infection.

Fifty-five physicians signed a letter spearheaded by the AIDS Healthcare Foundation citing concerns about the use of Gilead’s Truvada (tenofovir disoproxil fumarate and emtricitabine) for “pre-exposure prophylaxis,” or PrEP. Concerns included the risk of a decrease in condom use and a lack of information showing proper use in “real world” situations.

June 30, 2011

A new study that combined three separate cohorts conducted by researchers at the Harvard School of Public Health found that such lifestyle factors as diet may influence long-term weight gain.

BOSTON — A new study that combined three separate cohorts conducted by researchers at the Harvard School of Public Health found that such lifestyle factors as diet may influence long-term weight gain.

The study pooled data from 120,877 U.S. women and men who were free of chronic diseases and not obese at the beginning of the study, with follow-up periods from 1986 to 2006, 1991 to 2003, and 1986 to 2006. Patients were followed up at four-year intervals, researchers said.

June 30, 2011

Drug maker UCB and Harvard University have entered a research alliance that is designed to advance ongoing Harvard research projects along the drug development pathway.

BOSTON and BRUSSELS — Drug maker UCB and Harvard University have entered a research alliance that is designed to advance ongoing Harvard research projects along the drug development pathway.

UCB said it will bring its expertise in antibody generation and medicinal chemistry into the alliance and will provide up to $6 million over two years to fund specific innovative research projects led by Harvard scientists. The collaboration focuses on the central nervous system and immunology, UCB said.

June 30, 2011

Canadian drug maker Valeant Pharmaceuticals International will acquire rights to topical drugs for eczema and cold sores from Swedish drug maker Meda.

MISSISSAUGA, Ontario — Canadian drug maker Valeant Pharmaceuticals International will acquire rights to topical drugs for eczema and cold sores from Swedish drug maker Meda.

Valeant said it would buy rights for the eczema drug Elidel (pimecrolimus) and the cold sore drug Xerese (acyclovir and hydrocortisone) for the United States, Canada and Mexico. Valeant said, however, that Xerese has not yet received regulatory approval in Canada.

June 29, 2011

Adding an investigational drug for Type 2 diabetes to the common generic drug metformin helped control blood sugar in patients who could not control their blood sugar with metformin alone, according to results of a late-stage clinical study.

SAN DIEGO — Adding an investigational drug for Type 2 diabetes to the common generic drug metformin helped control blood sugar in patients who could not control their blood sugar with metformin alone, according to results of a late-stage clinical study.

June 29, 2011

Important safety information often is missing from drug labels, while some pharmacies don’t include medication guides required by the federal government, according to a new investigation by Consumer Reports.

YONKERS, N.Y. — Important safety information often is missing from drug labels, while some pharmacies don’t include medication guides required by the federal government, according to a new investigation by Consumer Reports.