FDA finds contaminants in drug linked to meningitis

(Reuters) – The U.S. Food and Drug Administration said on Friday it found “greenish black foreign matter” and other contaminants in an injectable steroid produced by the New England Compounding Center, the pharmacy at the heart of a deadly U.S. meningitis outbreak. It also found that vials from the same bin of the steroid contained what appeared to be a “white filamentous material,” according to the report released by the FDA following inspections of the facility in October. …

FDA approves Eisai’s drug to treat epileptic seizures

(Reuters) – U.S. health regulators approved Japanese drugmaker Eisai Co Ltd’s Fycompa tablets to treat partial seizures in epileptic patients, saying current treatments on the market were unsatisfactory in controlling seizures in some patients. Eisai’s drug, chemically known as perampanel, works by blocking the action of the neurotransmitter glutamate, which may cause excessive electrical activity in the brain, resulting in seizures. “It is important to have a variety of treatment options available for patients with epilepsy,” said Russell Katz, an official at the U.S. …

U.S. House panel seeks FDA documents on meningitis-linked firm

WASHINGTON (Reuters) – A U.S. congressional committee that oversees drug safety issues asked the Food and Drug Administration on Wednesday to provide documents on federal and state inspections of a Massachusetts pharmacy linked to a deadly meningitis outbreak that has killed 19 people. In a letter to FDA Commissioner Margaret Hamburg, the House of Representatives Energy and Commerce Committee said it was requesting documents dating back to 2004 as part of a probe to determine what actions regulators took after they concluded that the pharmacy’s facilities posed potential risks to public …

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