Industry News

Pfizer on January 31 announced the recall of 28 lots of oral contraceptive tablets because of problems with the packaging configurations.

Not all cans bearing the label "Renastart" and marked "Batch No. 12832" on the bottom contain that medical food, which is intended specifically for patients 1 year or older with renal failure, Vitaflo USA LLC announced Monday. In following up on a customer's complaint, the company discovered that a medical food other than Renastart may have been labeled as such.

FDA today announced the approval of ivacaftor, an oral therapy that the agency called a breakthrough in personalized medicine for people with a rare form of cystic fibrosis (CF).

Genentech and FDA today announced the approval of vismodegib, or Erivedge, for the treatment of adults with locally advanced basal cell cancer who are not candidates for surgery or radiotherapy or whose cancer has metastasized.

Cephalon Inc. is recalling Treanda lot TB30111, containing bendamustine hydrochloride, because glass fragments were found in one of the vials, according to a press release circulated today by FDA.

FDA on January 27 announced the approval of axitinib as second-line therapy in patients with advanced renal cell carcinoma that has not responded to previously administered systemic agents.

How many onsite pharmacists does it take to oversee the dispensing of medications and refilling of automated dispensing cabinets in a Kansas hospital?

With little fanfare, FDA has been following up on a plan to free manufacturers from the need to implement risk evaluation and mitigation strategy (REMS) programs that consist solely of a medication guide.

The mysterious link between one manufacturer’s intravenous immune globulin (IVIG) product and an unusual rate of thrombotic and thromboembolic events is now known—too much coagulation factor XIa. But the company’s resolution of that issue does not mean pharmacists can relax their efforts to minimize the risk of adverse events related to the manufacture of IVIG products, said two experts.

FDA has approved the marketing of ingenol mebutate gel, or Picato, for the topical treatment of actinic keratosis, Leo Pharma Inc. announced today.

Teva Pharmaceuticals USA Inc. is recalling several lots of the company's medroxyprogesterone acetate injectable suspension vials and syringes because they contain silicone particles, according to FDA's Enforcement Report dated January 18.

FDA on Tuesday approved the marketing of glucarpidase, or Voraxaze, for the treatment of toxic plasma methotrexate concentrations in patients whose kidneys are not eliminating the drug at a normal rate.

As pharmacy practice evolves, so do the strategies that help drive those changes—including the ambitious and comprehensive Pharmacy Practice Model Initiative (PPMI), which has supplanted ASHP's 2015 Initiative.

A total of 37 new molecular entities, vaccines, and blood products won FDA marketing approval last year, compared with 29 in the previous year. Highlights of several of the approved medications appear below. A full list of new products and their indications appears below.

Rexall Inc. on Monday announced the recall of one lot of calcium and vitamin D3 softgels in 60-count bottles.

About three minutes into a congressional hearing on drug shortages, U.S. Representative Joseph R. Pitts acknowledged one of the health care professionals who had initially raised the issue with the Pennsylvania congressman and his staff.

Health care facilities that still have vecuronium bromide and polymyxin B from Bedford Laboratories should examine the lot numbers. The company on Tuesday issued "updated guidance" suggesting that its August 2011 recall—initiated because of "discovery of a visible glass particle in a limited number of vials within the lots"—is still ongoing.

Problems at a Novartis factory in Lincoln, Nebraska, that makes products for Endo Pharmaceuticals have led to the recall of several nonprescription medications and a plea to pharmacists to verify the contents of containers of specific opioid drugs before dispensing them.

Patients with ventilator-associated pneumonia (VAP) who received doripenem in a clinical study fared worse overall than similar patients who received imipenem–cilastatin, according to an FDA safety announcement posted on Thursday.

As 2011 drew to an end, Congress held a fourth hearing on the nation’s shortage of prescription drugs.