Industry News

A majority of advisers to FDA recommended that the agency restrict the use of rosiglitazone or ban the drug altogether to minimize the risk of ischemic cardiovascular adverse events in patients with type 2 diabetes mellitus.

FDA announced today that it is reviewing reports of premature puberty in young girls, gynecomastia in young boys, and other adverse events in pets unintentionally exposed to estradiol transdermal spray.

A rare, serious pneumonia can develop in patients receiving daptomycin, FDA announced today in a drug safety communication.

To achieve “true meaningful use” of a computerized prescriber-order-entry (CPOE) system, according to the organization known as the Leapfrog Group, a hospital must routinely test and monitor that system after implementation.

A $126,500 investment by the federal government in the early part of the 2000s decade helped set the stage for clinical pharmacy services provided by three pharmacists who still practice at their community health center.

About a third of the new molecular entities and biological products approved by FDA during the first half of 2010 have required a risk evaluation and mitigation strategy, or REMS, to satisfy the agency's requirements for marketing the product.

GlaxoSmithKline and FDA announced today that some of the Advair Diskus inhalers stolen nearly a year ago from a company warehouse in Virginia were recently found in pharmacies.

FDA announced today that it is investigating whether a meta-analysis's finding of a small increased risk of cancer in users of angiotensin receptor blockers (ARBs) means that this type of drug causes cancer.

Bristol-Myers Squibb on Monday announced a recall of eight lots of Coumadin 1-mg tablets in blister packs intended for use in hospitals or as samples.

FDA on July 9 announced that life-threatening air or gas embolisms have occurred in surgery patients during or immediately after the use of air- or gas-pressurized sprayers to apply hemostatic drugs or biologicals.

A continuing internal review by McNeil Consumer Healthcare has resulted in the company announcing today the recall of 21 more lots of nonprescription products.

FDA today announced the creation of a medication guide, or MedGuide, for quinine sulfate as part of a new risk evaluation and mitigation strategy (REMS) (PDF) to warn patients about the risks of off-label use of the antimalarial drug.

There is an important correction to the monograph for Piperacillin Sodium–Tazobactam Sodium in Pediatric Injectable Drugs, Ninth Edition (the Teddy Bear Book), published by ASHP.

Israel-based Kamada on July 2 announced the U.S. licensing of Glassia, an i.v. alpha1-proteinase inhibitor product, for use as chronic augmentation and maintenance therapy in patients with emphysema caused by a congenital deficiency of alpha1-antitrypsin.

Purdue Pharma LP announced Thursday that its new buprenorphine transdermal system, Butrans, received marketing approval from FDA and has a risk evaluation and mitigation strategy (REMS).

A long-standing shortage of technetium 99m (99mTc) generators has nuclear pharmacists changing their methods so that patients can receive critical imaging studies.

The Navy Bureau of Medicine’s investment in telepharmacy is giving isolated Navy pharmacy technicians real-time access to a pharmacist—in some cases, for the first time ever.

Consumers should discard all their Sinex Nasal Spray and VapoSpray 4-Hour Nasal Spray by Sinex having an expiration date before June 2013, Procter & Gamble Company announced Thursday.

FDA and Pfizer Inc. on Monday announced the withdrawal of gemtuzumab ozogamicin, or Mylotarg, from the U.S. market because the acute myeloid leukemia drug has not proved to be safe and effective since it was approved 10 years ago under an accelerated mechanism.

FDA and Sanofi-Aventis on Thursday announced the approval of cabazitaxel, in combination with prednisone, to treat androgen-independent prostate cancer in men who have already received docetaxel.