Regulatory and Washington

SAN DIEGO — The Food and Drug Administration has given special designation to a drug under development by Mast Therapeutics for a rare disease that restricts the flow of blood to the limbs.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare and aggressive type of blood cancer, the agency said Wednesday.

The FDA announced the approval of Imbruvica (ibrutinib), marketed by Pharmacyclics and Johnson & Johnson, for treating mantle cell lymphoma, or MCL. MCL is a rare form of non-Hodgkin lymphoma and represents about 6% of all non-Hodgkin lymphoma cases in the United States. Millennium Pharmaceuticals' Velcade (bortezomib) and Celgene's Revlimid (lenalidomide) are also approved for treating MCL.

WASHINGTON — As cold and flu season kicks into high gear, the Acetaminophen Awareness Coalition on Tuesday issued a nationwide safety message urging consumers to double-check their medicine labels so they don’t double-up on medicines that contain acetaminophen when treating winter illnesses. 

WASHINGTON — Greater use of statins in reducing the risk of high cholesterol is among the long-awaited new guidelines for treating lipid and weight disorders.

WASHINGTON — The chairman of the Senate Health, Education, Labor and Pensions Committee highlighted the human tragedy wrought by last year's fungal meningitis outbreak linked to contaminated injectable steroids as he spoke in favor of a new law that would regulate compounding pharmacies and implement federal track-and-trace policies for drugs during a recent speech.

PHILADELPHIA — According to an article published in Annals of Internal Medicine Monday, a systematic review of published studies found insufficient evidence that vitamin and mineral supplements are effective for preventing cardiovascular disease, cancer or mortality from those diseases in healthy adults. 

SILVER SPRING, Md. — The Food and Drug Administration on Sunday announced that USPlabs of Dallas is recalling certain OxyElite Pro dietary supplement products that the company markets. 

The company took this action after receiving a letter from the FDA stating that the products have been linked to liver illnesses, and that there is a reasonable probability that the products are adulterated.  

BURLINGTON, Vt. — The voluntary action taken five years ago by manufacturers of cough and cold medicines — namely to no longer recommend the use of OTC cough-cold products in children under the age of 4 years unless directed to do so by a doctor — has worked, according to a study published Monday online by Pediatrics, the peer-reviewed journal of the American Academy of Pediatrics.