Content about 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.

ALEXANDRIA, Va. — 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.

WASHINGTON — 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.

OSAKA, Japan — 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.

Takeda announced that it resubmitted its applications for alogliptin and a drug that combines alogliptin with pioglitazone, the active ingredient in Actos, which the FDA approved in 1999.

The FDA will review the applications over the next six months, the drug maker said.

July 25, 2011


The Food and Drug Administration last month published long-awaited draft guidance on new dietary ingredients in the Federal Register.


The Food and Drug Administration last month published long-awaited draft guidance on new dietary ingredients in the Federal Register. Once finalized, the guidance will establish an additional pillar of credibility to the dietary supplement industry and help counter criticism that the FDA does not regulate the safety of supplement products — that is, if the FDA doesn’t force supplements off the shelf that are already on the shelf today. 


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.


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.

SUPPLIER NEWS — 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. Janssen Pharmaceuticals announced the approval of Xarelto (rivaroxaban) tablets as a once-daily oral anticoagulant for DVT, a condition that could lead to pulmonary embolism.


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.

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

Daiichi Sankyo announced the FDA approval of Welchol (colesevelam hydrochloride) for oral suspension to be mixed with fruit juice or diet soft drinks. The drug, used to improve blood-sugar control and cholesterol levels in patients with Type 2 diabetes and high cholesterol, received approval in 2009 for mixing with water.

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.

HORSHAM, Pa. — 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.

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

“You’re in the drug store, looking for a fever-reducing medicine for your children,” the message begins. “They range in age from 6 months to 7 years, and you want to buy one product you can use for all of them. So you buy liquid acetaminophen in concentrated drops for infants, figuring you can use the dropper for the baby and a teaspoon for the oldest.”

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.

ALLEGAN, Mich. — 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.

The product will be marketed under store-brand labels and is comparable with GlaxoSmithKline's Nicorette Cinnamon Surge coated gum, a stop-smoking aid.

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.

WILMINGTON, Del. — 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.

AstraZeneca announced the approval of Brilinta (ticagrelor), a blood-thinning drug, on Wednesday. The drug maker is touting the drug as an alternative to Plavix (clopidogrel), made by Sanofi and Bristol-Myers Squibb.

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.

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

The FDA approved a REMS for Fentora (fentanyl) buccal tablets and Actiq (oral transmucosal fentanyl citrate). Both drugs are used for managing breakthrough pain in cancer patients who have become tolerant of opioid drugs.

July 21, 2011

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

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

Lannett announced the approval of phentermine hydrochloride capsules in the 37.5-mg strength, a generic version of Teva’s Adipex-P.

Phentermine hydrochloride capsules in the 37.5-mg strength had sales of about $8.8 million during the 12-month period ended in May, according to Wolters Kluwer.

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.

WILMINGTON, Del. — 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.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 9-6 against recommending approval for dapagliflozin, saying that data from a two-year clinical trial program that included about 6,000 people did not support the drug’s approval for use in patients along with changes to diet and exercise.

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.

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

The chat session will begin at 3 p.m. on Twitter.com/US_FDA.

July 19, 2011

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

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

The agency approved Zyclara (imiquimod) cream in the 2.5% strength for AK, a precancerous lesion that affects about 10 million Americans and can develop into skin cancer later on.

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.

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

The FDA said six manufacturers are licensed to produce vaccines. These include GlaxoSmithKline Biologicals, manufacturing Fluarix; CSL Limited, manufacturing Afluria; ID Biomedical, manufacturing FluLaval; MedImmune Vaccines, manufacturing FluMist; Novartis Vaccines and Diagnostics, manufacturing Fluvirin; and Sanofi Pasteur, manufacturing Fluzone.

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.

DEERFIELD, Ill. — 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.

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

QRxPharma announced that it had filed a regulatory approval application with the Food and Drug Administration for MoxDuo IR (morphine and oxycodone). The drug is designed to release both drugs into the body immediately.

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.

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

Shire announced the approval of Lialda (mesalamine) delayed-release tablets for the maintenance of remission in patients with the disease.

The drug was already approved for inducing remission in patients with ulcerative colitis, an inflammatory disease that affects the colon and causes chronic inflammation, sores and ulcers.

July 15, 2011

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

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

Dr. Reddy’s and Brisbane, Australia-based Alchemia announced the FDA approval of fondaparinux sodium injection in the 2.5 mg/0.5 mL, 5 mg/0.4 mL, 7.5 mg/0.6 mL and 10 mg/0.8 mL strengths. Alchemia owns the patents covering the process for synthesis of fondaparinux.

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.

SILVER SPRING, Md. — 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.

The FDA said the change applies to the oral suspension form of Genentech’s Tamiflu (oseltamivir). The formulation is a powder that the pharmacist mixes with water to make it easier to take for patients who have difficulty swallowing capsules.

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.

PLANEGG-MARTINSRIED, Germany — 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.

4SC announced that it received the designation for resminostat, currently in phase-2 clinical trials as a treatment for hepatocellular cancer, or HCC. The FDA grants orphan drug designation to drugs for diseases that affect fewer than 200,000 people in the United States.

July 11, 2011

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

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

The FDA announced the approval of GlaxoSmithKline’s Boostrix, a single-dose booster shot described as the first vaccine approved for preventing all three diseases in patients ages 65 years and older.