Regulatory and Washington

PHILADELPHIA — GlaxoSmithKline has changed prescribing information on the labeling for one of its Type 2 diabetes drugs to reflect new restrictions on the drug’s use, the drug maker said.

GSK said it revised the labeling for Avandia (rosiglitazone) to take into account the risks of heart attacks and heart failure in patients taking the drug.

The FDA moved to restrict access to Avandia last year and required GSK to create a risk evaluation and mitigation strategy for the drug.

WASHINGTON — The Department of Health and Human Services on Friday launched a new Web portal that very well could make niche marketing of pharmaceutical and over-the-counter medicines easier to execute.

The portal, called the Health Indicators Warehouse, represents a collection of health and healthcare indicators that can be parceled out by:

FOSTER CITY, Calif. — Gilead Sciences has refiled an approval application with the Food and Drug Administration for an HIV drug, the drug maker said.

Gilead said it had resubmitted its application for a single-tablet combination of Truvada (emtricitabine and tenofovir disoproxil fumarate) and Johnson & Johnson subsidiary Tibotec Pharmaceuticals’ investigational drug TMC278 (rilpivirine hydrochloride) to treat HIV-1 infection in adults.

ALEXANDRIA, Va. — The National Community Pharmacists Association has expressed support of legislation that seeks to overturn two provisions in the Obama healthcare law that limit a patient’s choice in how to use consumer-directed health savings plans.

WASHINGTON — Recent restrictions imposed on flexible spending accounts appear to be the first piece of ObamaCare to be challenged by the new Congress.

Sen. Kay Bailey Hutchison, R-Texas, and Rep. Erik Paulsen, R-Minn., on Thursday respectively introduced The Patients’ Freedom to Choose Act, a bill that would repeal two provisions in the Obama healthcare law that limit a patient’s choice in how to use consumer-directed health savings plans, to the Senate and House of Representatives.

ATLANTA — The Centers for Disease Control and Prevention measured a steady rise in influenza — both in number of cases and severity — for the week ended Feb. 5.

There are 19 states that now are experiencing high levels of influenza-like illnesses as measured by outpatient visits — a measuring stick that provides a sense as to how severe the flu might be in a community but not how prevalent it is. The proportion of outpatient visits for ILI was 4.6%, which is above the national baseline of 2.5%.

SILVER SPRING, Md. —The Food and Drug Administration announced Friday the approval of Waltham, Mass.-based Thermo Fisher’s QMS Everolimus Immunoassay, a test that monitors the blood for levels of Novartis’ drug Zortress (everolimus).

Zortress is a drug used to prevent rejection of transplanted kidneys.

“QMS Everolimus is the first FDA-cleared test physicians can use to maintain appropriate levels of the immunosuppressant everolimus,” FDA Center for Devices and Radiological Health director Jeffrey Shuren said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for preventing preterm births.

The agency announced Friday the approval of Baxter Pharmaceutical Solutions’ Makena (hydroxyprogesterone caproate) injection, for reducing the risk of preterm delivery before 37 weeks of pregnancy in pregnant women with a history of at least one spontaneous preterm birth.