Court dismisses AstraZeneca case against FDA
NEW YORK — A federal court has dismissed a case that drug maker AstraZeneca filed against regulators regarding a drug used to treat psychotic and bipolar disorders, the company said Monday.
The U.S. District Court for the District of Columbia dismissed AstraZeneca’s lawsuit against the Food and Drug Administration over generic formulations of Seroquel (quetiapine fumarate) and its extended-release version, Seroquel XR. The roots of the lawsuit go back to September 2011, when the drug maker asked the agency to withhold approval of any generic version of the drug whose labeling didn’t include warning language about risks of elevated blood sugar and suicide that it had required AstraZeneca to include.
The FDA turned down AstraZeneca’s request on March 7, prompting the company to sue the agency five days later. The company had requested an injunction against the FDA’s approval of any generic version of Seroquel until the Dec. 2, 2012 expiration of clinical trial data.
"Notwithstanding the court’s decision, the company continues to believe strongly in the merits of its position and is evaluating its options," a statement by AstraZeneca read.
Supreme Court hears arguments surrounding healthcare law
WASHINGTON — The U.S. Supreme Court justices have gathered this week to discuss a potential legal issue surrounding President Obama’s healthcare law.
This week, the Supreme Court justices heard arguments for 90 minutes surrounding a legal issue pertaining to the Patient Protection and Affordable Care Act. The issue at hand is that "taxpayers who don’t purchase health insurance will have to report that omission on tax returns for 2014 and will pay a penalty along with federal income tax. At issue is whether that penalty is a tax," according to the Associated Press.
Meanwhile, last Friday marked the two-year anniversary of the enactment of the Patient Protection and Affordable Care Act. In line with the anniversary, the White House issued a report that aimed to highlight the benefits of the healthcare law. According to the Department of Health and Human Services secretary Kathleen Sebelius, new data found that seniors saved more than $3.2 billion on prescription drugs under the new healthcare law, while savings for seniors included a one-time $250 rebate check to those who hit the "donut hole" coverage gap in 2010 and a 50% discount on covered brand-name drugs in the donut hole in 2011.
Click here for the full report from AP.
FDA approves Teva allergy drug
JERUSALEM — The Food and Drug Administration has approved a drug made by Teva for treating allergies, the company said Monday.
Teva announced the approval of Qnasl (beclomethasone dipropionate) for seasonal and year-round nasal allergies in patients ages 12 years and older. The company said the drug, a "dry" nasal aerosol, would become available next month.
"There are some patients with allergic rhinitis who report dissatisfaction with the currently available therapies," Dallas Asthma and Allergy Center allergist Gary Gross said in a statement on behalf of Teva. "The approval of Qnasl offers these patients a safe and effective treatment option with a new dry mode of delivery."