August 3, 2011

Five trade associations representing the dietary supplement industry on Wednesday collectively requested a time extension to provide comments concerning the recent draft guidance on new dietary ingredient notifications that was recently issued by the Food and Drug Administration.

August 2, 2011

The Food and Drug Administration has approved an opioid painkiller made by Covidien's generic drug division, the medical supply company said.

August 2, 2011

The Food and Drug Administration has approved a new use for a drug made by Novartis for treating multiple sclerosis, the Swiss drug maker's U.S. subsidiary said Monday.

August 2, 2011

The Food and Drug Administration has given tentative approval to an emergency treatment for severe allergic reactions made by Intelliject, the drug maker said.

August 2, 2011

The Food and Drug Administration last week issued a warning letter to Terry Harris of HBB — makers of the controversial Lazy Larry and Lazy Cakes melatonin-spiked brownies — alerting Harris that HBB's products are adulterated with an unapproved food additive.

August 2, 2011

The Food and Drug Administration is looking for comments from consumers, the food industry and others about proposed labeling for gluten-free foods.

August 2, 2011

The Food and Drug Administration on Friday warned U.S. consumers not to use the emergency birth control medicine labeled as Evital, as it may be a counterfeit version of the “morning after pill” and may not be safe or effective in preventing pregnancy.

August 2, 2011

The Food and Drug Administration has granted orphan drug designation to a chemotherapy drug made by Merrimack Pharmaceuticals for pancreatic cancer, the drug maker said Monday.

August 1, 2011

CytoSport recently reported its receipt of a letter from the San Francisco office of the Food and Drug Administration alerting the company to concerns about its use of the word “milk” in its Muscle Milk trade name and to questions about the language used to describe Muscle Milk to consumers.

August 1, 2011

The Food and Drug Administration has approved a drug made by Bristol-Myers Squibb for injection under the skin to treat rheumatoid arthritis, Bristol said Friday.

August 1, 2011

The Food and Drug Administration has approved a generic version of a short-term adjunct treatment for obesity.

August 1, 2011

In a report issued last week, the National Association of Boards of Pharmacy found that 96% of rogue websites analyzed continue to operate out of compliance with U.S. pharmacy laws, fuel prescription drug abuse and misuse, and provide an outlet for counterfeit medicines to enter the U.S. drug supply.

July 29, 2011

The Food and Drug Administration has asked Eisai to redo its regulatory application for a drug to treat epilepsy, Eisai said Friday.

July 29, 2011

The Food and Drug Administration has approved a generic drug for diabetes made by Indian generic drug maker Strides Arcolab.

July 28, 2011

Drug makers Eli Lilly, Amylin Pharmaceuticals and Alkermes are giving their long-acting form of an injected drug for Type 2 diabetes another try at the Food and Drug Administration.

July 28, 2011

The National Association of Chain Drug Stores announced on Thursday that it submitted comments to the U.S. Senate Health, Education, Labor and Pensions Committee, which held a hearing Thursday titled "FDA User Fees: Advancing Public Health," outlining community pharmacy's commitment to addressing drug safety and the appropriate use of prescription medications to help improve patient health.

July 27, 2011

The Council for Responsible Nutrition on Wednesday announced that Daniel Fabricant, director of the Division of Dietary Supplement Programs at the Food and Drug Administration, will deliver the keynote address at The Conference: CRN’s Annual Symposium for the Dietary Supplement Industry on Oct. 20 in Rancho Palos Verdes, Calif.

July 26, 2011

Japanese drug maker Takeda Pharmaceutical is reapplying for approval of two drugs to treat Type 2 diabetes after the Food and Drug Administration turned down its last applications, the company said.

July 25, 2011


The Food and Drug Administration last month published long-awaited draft guidance on new dietary ingredients in the Federal Register.

July 25, 2011

A phrase like “silent killer” sounds creepy enough on its own, but it’s an often-used one for a virus that, according to the Centers for Disease Control and Prevention, infects 1.3% to 1.9% of people in the United States.


July 25, 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.

July 25, 2011

The Food and Drug Administration has approved a new means of administration for a drug made by Daiichi Sankyo, the drug maker said Monday.

July 22, 2011

A panel of experts at the Food and Drug Administration has recommended that the agency approve a drug made by Johnson & Johnson as a treatment for ulcerative colitis in children.

July 22, 2011

The Food and Drug Administration on Friday refreshed its Consumer Updates page with information regarding the danger of acetaminophen overdose in children.