Content about Regulatory and Washington

PRINCETON, N.J. — The Food and Drug Administration has approved a generic heart-disease drug made by Sandoz, the company said Wednesday.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of candesartan cilexetil tablets, a generic version of AstraZeneca's Atacand.

The drug is used to treat some types of heart failure in adults with left ventricular systolic dysfunction, as well as high blood pressure in adults and children as young as 1.

Atacand had sales of $120.3 million in 2012, according to IMS Health.

LEESBURG, Va. — The prevalence of chronic diseases, increased demand for patient care and failure of many patients to take their medications as prescribed calls for an increased role in the healthcare system for pharmacists, according to a national organization of pharmacies.

WASHINGTON — A recent survey commissioned on behalf of a pharmacy benefit manager trade group found a high degree of satisfaction among Medicare Part D beneficiaries with preferred pharmacy plans.

WASHINGTON — The mayor of the nation's capital announced Thursday plans to include calorie information on vending machines in municipal buildings.

Washington mayor Vincent Gray said the rollout of the Calories Count Vending Program would give workers and visitors the information they need to make wise lifestyle choices and would ultimately help reduce healthcare costs.

"This program is a great example of a public-private partnership that empowers consumers," Gray said.

WASHINGTON — The National Consumers League and its partners on Thursday announced the awardees of the second annual Script Your Future Medication Adherence Team Challenge for health profession students. This month-long competition engaged health profession students and faculty in developing creative ideas for raising awareness about medication adherence as a critical public health issue. This year's awardees are: St. Louis College of Pharmacy, University of Charleston School of Pharmacy, University of the Pacific Thomas J.

WASHINGTON — The Congressional Dietary Supplement Caucus on Monday held an educational briefing, “Sports Health and Fitness: The Role of Dietary Supplements,” for Capitol Hill staff. This is the second DSC educational briefing for the 113th Congress and the 17th briefing since the DSC was formed in 2006. 

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a drug for a type of lung cancer.

Roche subsidiary Genentech and the U.S. subsidiary of Japan's Astellas Pharma announced the approval of Tarceva (erlotinib) for advanced non-small cell lung cancer whose tumors have mutations that activate the epidermal growth factor receptor. The FDA also approved a test to detect the mutation.

The drug was already approved for advanced NSCLC that did not exhibit the mutation.

PITTSBURGH — The Food and Drug Administration has approved a generic migraine drug made by Mylan, the company said Wednesday.

Mylan announced the approval of zolmitriptan tablets in the 2.5 mg and 5 mg strengths. The drug maker plans to launch the product immediately.

The drug is a generic version of IPR Pharmaceuticals' Zomig and is used for the acute treatment of migraine in adults. Various versions of the drug had sales of $152.8 million during the 12-month period that ended in March, according to IMS Health.

BALTIMORE — The University of Maryland School of Pharmacy is piloting a program that will allow state employees to receive medication therapy management services, the university announced.

PARSIPPANY, N.J. — The Food and Drug Administration will review an experimental contraceptive patch made by Actavis, the drug maker said Tuesday.

Actavis said the FDA accepted for review its application for norethindrone transdermal delivery system. The patch, which does not yet have a brand name, is designed to provide continuous delivery of norethindrone during a once-weekly, seven-day dosing regimen.

WASHINGTON — Finals can be a stressful time for any college or graduate student, with many hours spent studying and few spent socializing or relaxing. But many students are using prescription drugs to get through finals, according to a new study.

SILVER SPRING, Md. — A ruling by the Food and Drug Administration means that generic versions of an opioid painkiller made by Endo Pharmaceuticals can stay on the market, drawing criticism from the drug maker.