Regulatory Affairs Syndicator

Bristol-Myers Squibb Company announced that the US Food and Drug Administration (FDA) has granted accelerated approval of Sprycel, an oral inhibitor of multiple tyrosine kinases, for the treatment of adults in all phases of chronic myeloid leukaemia (CML) (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy, including Gleevec (imatinib

Winston-Salem Journal - Other treatments approved by the Food and Drug Administration can arrest progression of the disease, which can lead to blindness in just weeks or months, but none has been shown to reverse deteriorating vision. Genentech may find Lucentis competing …

In 2005, Wyeth Pharmaceuticals notified health care professionals that Phenergan brand promethazine hydrochloride was contraindicated in children under the age of two because the drug could cause fatal respiratory depression. Now, the labeling on al…

Over the past year, Baxter Healthcare Corporation has issued four urgent safety notices and recalls for the company?s Colleague infusion pump, specifying steps to be taken to address problems with the pumps. FDA is now recommending that users of Col…

FDA and NIOSH are alerting healthcare professionals that incorrect use of certain seals in oxygen regulators can result in fires and are recommending an important precaution to avoid such fires.

FDA has received 12 reports in which regulators used…

The dental supply company Pascal is recalling the company’s anticavity fluoride rinses because they could be contaminated with bacteria that may cause pneumonia, including Burkholderia cepacia and Pseudomonas aeruginosa.

The recall affects all lo…

FDA is notifying healthcare professionals about an association between oral sodium phosphates (OSPs) for bowel cleansing and a type of acute renal failure called acute phosphate nephropathy. These occurrences, which are rare but serious, have been a…

The distributor IVAX Pharmaceuticals is recalling certain lots of 500 mg acetaminophen tablets and capsules because there’s an error on the product label.

The label incorrectly says, “Do not exceed 12 tablets or capsules in a 24 hour period,” wh…

GlaxoSmithKline is notifying healthcare professionals about new warnings on the risk of suicidality with Paxil (paroxetine) and Paxil CR. These labeling changes relate to adult patients, especially young adults, ages 18 to 24.

The company recent…

FDA and the Institute for Safe Medication Practices (ISMP) have launched a nationwide educational campaign to eliminate the use of potentially harmful abbreviations in all forms of medical communications. That includes written medication orders, com…

The Food and Drug Administration has approved Lucentis to treat macular degeneration. The problem is it’s incredibly expensive. Lucentis is the only drug shown to significantly reverse macular degeneration.

Associated Press - The pills cannot be sold in the United States for patent and/or exclusivity reasons, although they meet all U.S. standards for safety and efficacy, according to the Food and Drug Administration. The pills are eligible for distribution in 15 other …

The Food and Drug Administration has approved Lucentis to treat macular degeneration. The problem is it’s incredibly expensive. Lucentis is the only drug shown to significantly reverse macular degeneration.

Fake medicine firm fined, banned after 11 deathsChina Daily, China - 2 hours ago… of the Qiqihar No 2 Pharmaceutical Company, based in Northeast China, has also been revoked by the Heilongjiang provincial food and drug administration and th…

WASHINGTON (AP) - The strict “black-box'’ warning on the label of an HIV drug approved just last year is being updated to warn of sometimes fatal bleeding within the brain or skull tissue, health officials said Friday. The Food and Drug Administration said it has received 14 reports of intracranial hemorrhaging in patients treated in clinical trials with the drug, Aptivus, in combination with the