Various companies in the healthcare industry are uncertain about the benefits of the Food and Drug Administration’s risk evaluation and mitigation strategy program, and most think it needs a major overhaul, according to a study by the Tufts University Center for the Study of Drug Development.
PITTSBURGH — The Centers for Disease Control and Prevention and the Food and Drug Administration last year initiated programs that will breathe new life into sales of smoking-cessation products. The surgeon general issued a report titled “How Tobacco Smoke Causes Disease,” and the FDA will be mandating that tobacco manufacturers have smoking-is-bad-for-you messages on packaging.
Food and Drug Administration principal deputy commissioner Joshua Sharfstein will leave the agency to become head of the Maryland Department of Health and Mental Hygiene, according to published reports.
Supplier News — The Food and Drug Administration has approved a generic drug for hypertension made by Mylan. Mylan announced the approval of nifedipine extended-release tablets in the 30-mg, 60-mg and 90-mg strengths. The drug is a generic version of Bayer’s Adalat CC. Nifedipine tablets had sales of around $82 million during the 12-month period ended June 2010, according to IMS Health.
Responding to what she termed an “unprecedented” shortage of prescription medicines for such serious conditions as cancer, Sen. Amy Klobuchar, D-Minn., is promising new legislation to deal with the problem.
Merck on Wednesday announced that the Food and Drug Administration has approved Gardasil [human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant] for the prevention of anal cancer in males and females 9 to 26 years of age.