December 18, 2013

The Food and Drug Administration has approved a new drug made by GlaxoSmithKline and Theravance for treating chronic obstructive pulmonary disease, the agency said Wednesday.

December 16, 2013

The Food and Drug Administration may require makers of antibacterial soaps to perform clinical trials to show their products are better at preventing infections and disease than ordinary soaps.

December 11, 2013

The Food and Drug Administration has approved the first generic versions of a drug used to treat depression and other conditions, the agency said.

December 11, 2013

The Food and Drug Administration is planning to limit the use of antimicrobials in food animals in an effort to stem the rise of antibiotic-resistant bacteria, the agency said Wednesday.

December 10, 2013

Only a quarter of respondents to a new survey would call a doctor for advice when someone at home has the flu, despite widespread recognition of it as serious and of the need for vaccination.

December 9, 2013

BioElectronics on Monday announced that Boots will be selling its ActiPatch Pain Therapy products in select stores for back, knee and musculoskeletal ailments.

December 9, 2013

Further expanding the scope of preventive healthcare services provided by its pharmacists, Walgreens is now offering daily testing for cholesterol, blood glucose and body composition at more than 60 stores in Maryland.

December 6, 2013

The Food and Drug Administration has approved a treatment for a sexual deformity that affects men.

December 6, 2013

Supervalu on Friday announced a new fleet of environmentally-friendly delivery trucks that operate on compressed natural gas.

December 4, 2013

The Food and Drug Administration issued a safety communication on HeartStart automated external defibrillators from Philips Healthcare.

December 3, 2013

Paula Price is stepping down as Ahold USA's EVP and CFO, the supermarket operator said Tuesday.

December 3, 2013

The Food and Drug Administration has given tentative approval to a generic drug for treating community-acquired pneumonia, agency records showed.

December 3, 2013

The Food and Drug Administration has given tentative approval to a generic drug used to treat prostate disease, agency records showed.

November 27, 2013

A new study is helping to provide a better understanding of vaccines for whooping cough, the Food and Drug Administration announced Wednesday.

November 25, 2013

Federal regulators are lifting some restrictions on a diabetes drug that were placed two years ago after studies linked the drug to increased cardiovascular risk.

November 22, 2013

The Food and Drug Administration has approved a drug made by Bayer HealthCare Pharmaceuticals for treating thyroid cancer, the agency said Friday.

November 21, 2013

Honest Tea, maker of organic bottled tea, is rolling out Unsweet Lemon Tea nationwide, the company announced.

November 20, 2013

Following actions by the Food and Drug Administration, USPLabs has agreed to recall and destroy the dietary supplement OxyElite Pro, as it has been linked to dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants, the agency noted Wednesday.

November 19, 2013

SILVER SPRING, Md. — At the request of the Food and Drug Administration, U.S. Marshals seized dietary supplements manufactured and held by Hi-Tech Pharmaceuticals, located in Norcross, Ga., after FDA investigators found the products contained 1, 3-Dimethylamylamine HCl (DMAA) or its chemical equivalent, the agency announced Monday.

“This company has a responsibility to ensure its products are safe for distribution and human consumption,” stated Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs. “We have taken action to protect consumers and demonstrate our commitment to their safety by keeping these products from entering the distribution system.”

The retail value of the seized products is more than $2 million, the agency estimated.

A complaint filed in the U.S. District Court for the Northern District of Georgia alleged that the products were adulterated according to the Federal Food, Drug, and Cosmetic Act because they contain DMAA, an unapproved food additive that is deemed unsafe under the law.

The FDA is urging consumers not to buy or use supplements containing DMAA, which can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest. Given the known biological activity of DMAA, the ingredient may be particularly dangerous when used with caffeine. Consumers should check labels and avoid any dietary supplements containing DMAA, which is referred to on different product labels by 10 possible names. The FDA has warned consumers about the health risks of DMAA on its web site.

On Nov. 12, 2013, U.S. Marshals seized more than 1,500 cases of finished goods and more than 1,200 pounds of in-process/raw material goods from the Hi-Tech Pharmaceuticals facility.

During the FDA’s inspection of Hi-Tech Pharmaceuticals, which began in October, investigators identified 11 products that were labeled as containing DMAA or its chemical equivalent. These products included Black Widow, ECA Xtreme, Fastin, Fastin-XR, Lipodrene, Lipodrene Hardcore, Lipodrene XR, Lipodrene Xtreme, Lipotherm, Stimerex-ES, and Yellow Scorpion. The investigators also observed bulk DMAA raw ingredients at the facility. Prior to the seizure, on Nov. 1, 2013, the FDA issued an administrative detention, temporarily holding the products until they were seized.

Dietary supplements containing DMAA are illegal and the FDA is using all available tools at its disposal to remove these products from the market. In 2012, the FDA issued warning letters to companies notifying them that products containing DMAA need to be taken off the market or reformulated to remove this substance.

November 18, 2013

The Environmental Protection Agency has recognized Ahold USA for its efforts to reduce food waste, the agency said.

November 14, 2013

The Food and Drug Administration has requested label and packaging changes of certain over-the-counter topical antiseptic products, according to an FDA MedWatch alert.

November 13, 2013

AstraZeneca specialty drugs division MedImmune will work with author Elizabeth Pantley to publish a new guide designed to educate parents on flu prevention.

November 12, 2013

Supermarket chain Giant Food of Landover, Md., has started a new way for non-profit organizations to use its gift cards to raise money.

November 12, 2013

Laboratory sciences company Waters Corp. has recognized the University of Maryland School of Pharmacy's Department of Pharmaceutical Sciences' mass spectrometry facility as the first to receive its Waters Centers of Innovation honors, the company announced at a ceremony Tuesday.