Industry News

FDA on Tuesday launched a new website for health care professionals and consumers that summarizes safety information about recently approved drugs and biological products.

A law that goes into effect July 1 affirms the ability of hospital pharmacists in Georgia to collaborate with medical staff members in managing drug therapies for patients in institutional settings.

Among the changes coming for participants in the Medicare Part D prescription drug benefit is the gradual closing of the much-maligned coverage gap*mdash;better known as the doughnut hole.

Design flaws, not user error, are the root cause of many problems associated with infusion pumps, say FDA officials who want the devices to be safer and more reliable.

Two large studies on the use of olmesartan in patients with type 2 diabetes mellitus have revealed higher rates of death from cardiovascular events in participants who received the drug instead of a placebo, FDA said today in announcing its ongoing review of the data.

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FDA posted a notice today stating that GammaGard Liquid lots LE12J370AB and LE12J379AB are being withdrawn from the market because of an increased number of reports of allergic reactions in recipients.

Amgen on June 1 announced the licensing of denosumab injection for use in postmenopausal women who have osteoporosis and are at high risk for fracture.

FDA has approved the marketing of hexaminolevulinate hydrochloride, or Cysview, for the detection of a type of superficial bladder cancer in patients suspected or known to have the disease, GE Healthcare announced May 28.

The company that markets the PediaCare line of pediatric cough and cold remedies has recalled four products that were made by McNeil Consumer Healthcare at that company's recently shuttered Fort Washington, Pennsylvania, manufacturing plant.

A May 29 public health alert from FDA warns against the use of potentially contaminated bags of i.v. metronidazole, ondansetron, and ciprofloxacin made by Claris Lifesciences Limited, of Ahmedabad, India.

The March 31 recall of propofol injectable emulsion and Liposyn fat emulsion products now includes more lots and dates of distribution, Hospira announced today in a press release posted by FDA.

Therapy with any of the available proton pump inhibitors (PPIs) is possibly linked to an increased risk of fractures of the hip, wrist, and spine, FDA announced Tuesday.

Members of the Institute of Medicine’s (IOM’s) roundtable on health literacy in April convened a diverse group of stakeholders to discuss how they can assist FDA in its efforts to help Americans use medications safely.

FDA and Genzyme Corporation on Tuesday announced the approval of a specific type of alglucosidase alfa for use in patients with Pompe disease who are 8 years of age or older, whose symptoms did not emerge soon after birth, and who have no evidence of cardiac hypertrophy.

Experts say the strategies people use to prevent cognitive decline and Alzheimer’s disease all have a common trait: no solid proof exists that any intervention works.

A "warning letter" issued recently by FDA to a company that markets gastrointestinal lavages and prescription laxatives and manufactures calcium acetate gel caps accuses the firm of not thoroughly investigating consumers' complaints about insects and insect parts in five finished products.

Sagent Pharmaceuticals yesterday announced a recall of all 500-mg/100-mL vials of metronidazole injection manufactured for the company by Claris Lifesciences in India.

Baxter International Inc. this morning announced a recall of all lots of Hylenex, a recombinant hyaluronidase injection product manufactured and marketed by the company.

FDA on Friday recommended that health care providers use the two U.S.-licensed rotavirus vaccines to protect infants from rotavirus infection, even though both products are now known to be contaminated with porcine circovirus (PCV) DNA.