March 28, 2011

The U.S. Pharmacopeial Convention last week announced that it is working with the Food and Drug Administration and the Consumer Healthcare Products Association to update quality standards for widely used medicines and ingredients. Updated test methodologies are crucial to help counter economically motivated adulteration — in which less expensive and potentially harmful ingredients are substituted for genuine medicines or their ingredients — and also to address the challenge of impurities that may go undetected with older, nonspecific assays and tests.

March 25, 2011

The Food and Drug Administration has approved a new treatment for late-stage skin cancer, the agency said Friday.

March 25, 2011

The Food and Drug Administration has approved a vaccine for shingles in older patients.

March 24, 2011

Sugar and chalk. That’s what Pfizer researchers found in a pill that was supposed to be Cytotec, but was, in fact, a crude knockoff seized from a counterfeit drug lab in Peru.

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.

March 24, 2011

Bristol-Myers Squibb said its late-stage clinical trial for a cancer treatment, which currently is under review by the Food and Drug Administration, achieved its primary endpoint.

March 24, 2011

The Food and Drug Administration has extended its regulatory review period for Novartis' new drug application for its once-daily, long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, as well as chronic bronchitis and/or emphysema, the drug maker said.

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.

March 24, 2011

The Consumer Healthcare Products Association may not be painting pink Pepto-Bismol mustaches on a group of Hollywood celebrities and professional athletes as part of the new campaign it plans to fully unveil in June, but the goal is more or less the same as the “Got Milk?” ads.

“Got milk?” has become ubiquitous. There is 100% clarity of message. The milk mustache says it all: Milk is an essential food and an integral part of a healthy diet; it HAS TO BE in your refrigerator, on your breakfast table and in your lunch box.

March 24, 2011

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

March 24, 2011

The Food and Drug Administration has approved a topical pain treatment made by Hi-Tech Pharmacal, the drug maker said Thursday.

March 24, 2011

The Food and Drug Administration has approved a generic drug for cardiovascular disease made by Qualitest Pharmaceuticals.

March 23, 2011

Though more than 7-in-10 drugs dispensed in the United States today are generics, and the Food and Drug Administration holds generics to the same standards as branded drugs, misgivings among the general public still exist, fed by the occasional media report of patients experiencing bad side effects after taking certain generic drugs.

March 22, 2011

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

March 21, 2011

The generic drug industry’s main lobby in Washington is hoping to head off cuts to the Food and Drug Administration’s Office of Generic Drugs, which it said could have a “devastating impact” on those who rely on generics.

March 21, 2011

Nature's Health Connection said its over-the-counter pain-relief cream has garnered record retail sales.

March 21, 2011

Generic drug maker Mylan is suing the Food and Drug Administration in an effort to prevent Gurgaon, India-based competitor Ranbaxy Labs from launching its generic version of Pfizer’s cholesterol medication Lipitor, according to published reports.

March 18, 2011

It's about time lawmakers start to understand the real threats posed by drug reimportation and unlicensed Internet pharmacy sites. About 20% of the current members of Congress are newly elected, and there is this recurring, cyclical fascination among politicians that we can fix everything with drug reimportation. But mandating electronic track and trace right now is a bad idea.

March 18, 2011

Due to the public concern related to the nuclear incident in Japan, there has been an increased demand for such drugs as potassium iodide (KI), used to prevent and treat the harmful effects of radiation, according to a Food and Drug Administration Web page updated Thursday.

March 18, 2011

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

March 18, 2011

Menthol-flavored cigarettes are the latest target for tobacco opponents, according to published reports.

March 17, 2011

Drug makers Gilead Sciences and Roche are suing Indian drug maker Natco Pharma concerning a generic version of an influenza treatment, according to published reports.

March 17, 2011

Anglo-Swedish drug maker AstraZeneca has enrolled the first patient in a late-stage clinical trial for a drug to treat constipation related to use of opioid painkillers, the company said.

March 17, 2011

Commenting on a counterfeit pharmaceutical inter-agency working group report, the National Association of Chain Drug Stores stressed that it shares the goal of improving the public awareness of the risks posed from counterfeit drugs and unlawful online drug sellers, but expressed concern over the report's proposal to mandate a "track-and-trace" system in the United States, given the high cost it could pose for pharmacies.