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.

November 11, 2013

The Food and Drug Administration on Sunday announced that USPlabs of Dallas is recalling certain OxyElite Pro dietary supplement products that the company markets.

November 8, 2013

The Food and Drug Administration has approved six generic versions of a drug used to treat gastroesophageal reflux disease, or GERD, the agency said Friday.

November 8, 2013

The Food and Drug Administration has approved a new drug for treating epileptic seizures, the agency said Friday.

November 8, 2013

When the maker of a branded drug updates the safety information on its product labeling, makers of generic versions of that drug must wait until the Food and Drug Administration approves the new labeling before they can update theirs, but that could soon change under a rule proposed by the FDA.

November 7, 2013

U.S. regulators made a preliminary move Thursday to remove trans fats from food products.

November 5, 2013

The Food and Drug Administration has approved a generic injectable antibiotic drug made by Emcure Pharmaceuticals, according to the agency.

November 5, 2013

The Food and Drug Administration has approved a generic drug made by Mylan for treating overactive bladder, according to agency records.

November 4, 2013

The Food and Drug Administration has asked Ariad Pharmaceuticals to suspend marketing and sales of a chemotherapy drug for leukemia due to the risk of life-threatening side effects, the agency said.

November 1, 2013

The Food and Drug Administration has approved a new drug for leukemia made by Genentech, the agency said Friday.

November 1, 2013

Ahold USA has appointed a former executive for Asian retailer Dairy Farm International as president of its Giant Food of Landover, Md., division, Ahold said Friday.

October 31, 2013

The Food and Drug Administration is using long-term strategies to address drug shortages when they appear and requiring manufacturers to notify the agency if a shortage is at risk of happening, under a new plan announced Thursday.

October 31, 2013

Earlier this year, the Food and Drug Administration approved a new drug for treating cystic fibrosis for patients who have a specific genetic mutation, but that also treats the underlying cause of the disease rather than the disease itself.

October 28, 2013

The Food and Drug Administration has launched an online learning course aimed at healthcare professionals to educate them about potentially untruthful or misleading drug ads and promotional materials.

October 25, 2013

The Food and Drug Administration has approved a new opioid painkiller made by Zogenix, the agency said Friday.

October 25, 2013

The Food and Drug Administration plans to recommend stronger regulations for a commonly used opioid painkiller.