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The Food and Drug Administration last month published long-awaited draft guidance on new dietary ingredients in the Federal Register.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

July 22, 2011

Perrigo on Thursday announced that it has received approval from the Food and Drug Administration to market a cinnamon-flavored, over-the-counter coated nicotine polacrilex gum USP in 2-mg and 4-mg strengths.

July 21, 2011

The Food and Drug Administration has approved a drug made by AstraZeneca to reduce the rate of heart attacks in patients with acute coronary syndrome, the Anglo-Swedish drug maker said.

July 21, 2011

The Food and Drug Administration has approved a risk evaluation and mitigation strategy for two painkillers made by Cephalon, the drug maker said Thursday.

July 21, 2011

The Food and Drug Administration has approved a drug for managing obesity made by Lannett.

July 20, 2011

A Food and Drug Administration committee of experts has advised against approving a drug for Type 2 diabetes made by AstraZeneca and Bristol-Myers Squibb, the companies said Tuesday.

July 19, 2011

The Food and Drug Administration will sponsor a chat session via Twitter concerning proposed guidelines for health-related apps, the agency said Tuesday.

July 19, 2011

The Food and Drug Administration has approved a drug made by Graceway Pharmaceuticals for actinic keratoses, Graceway said.

July 19, 2011

The Food and Drug Administration has approved a new influenza vaccine formulation for the 2011-2012 flu season, the agency said Monday.

July 18, 2011

Walgreens is recognizing medication adherence rates as high as 96% through its hepatitis C therapy management programs across its specialty pharmacy, the pharmacy operator announced Monday.

July 18, 2011

Australian drug maker QRxPharma is seeking approval for a drug that combines two painkillers in one pill, the company said Monday.

July 18, 2011

The Food and Drug Administration has approved a drug made by Shire for treating ulcerative colitis, the British drug maker said Monday.

July 15, 2011

The Food and Drug Administration has approved a generic anticoagulant drug made by Dr. Reddy’s Labs and Alchemia.

July 14, 2011

OSAKA, Japan — Two diabetes drugs made by Takeda Pharmaceutical Co. have been pulled from the market in France due to evidence that their use may increase the risk of bladder cancer, Takeda said.

Takeda said its French subsidiary, Laboratoires Takeda, would withdraw Actos (pioglitazone) and Competact (pioglitazone and metformin). In addition, Takeda said it was cooperating with the European Medicines Agency in a pan-European of pioglitazone. Competact is marketed in the United States under the brand name Actoplus Met.

July 13, 2011

A new formulation of a common drug for flu will be available in lower concentrations to reduce the possibility of medication errors, the Food and Drug Administration said Wednesday.

July 12, 2011

The Food and Drug Administration has granted orphan drug designation to a cancer treatment in mid-stage development made by German drug maker 4SC, the company said Tuesday.

July 11, 2011

The Food and Drug Administration has approved a vaccine for preventing tetanus, diphtheria and whooping cough in elderly patients.

July 8, 2011

The Natural Products Association on Thursday launched a grassroots campaign to oppose the Dietary Supplement Labeling Act, recently introduced in Congress by Sen. Richard Durbin, D-Ill., and is urging its more than 1,900 members to ask their legislators to oppose the legislation by sending them a letter at NPAinfo.org/Durbin.