Topic: Food and Drug Administration
Should healthy people with normal cholesterol take a daily statin drug to prevent heart problems? The question is dividing heart doctors and confusing patients. An analysis published Monday questions previous research that led to wider use of the AstraZeneca PLC drug Crestor. ...
Pfizer gets FDA warning letter for failing to report drug side-effect reportsFederal regulators have warned Pfizer for failing to promptly report complaints with its drugs that may have involved serious injury. Pfizer repeatedly failed to submit product complaints to the Food and ...
US Food and Drug Administration seeks more information on AstraZeneca's cholesterol drugAstraZeneca PLC and Abbott Laboratories said Tuesday that the U.S. Food and Drug Administration has asked for more information about their Certriad cholesterol drug before approving it for sale. The companies ...
WASHINGTON (Reuters) - Patients on the highest approved dose of the cholesterol-lowering drug Zocor may be at increased risk of muscle injury, U.S. regulators warned on Friday. Made by Merck & Co and sold under the brand name Zocor, simvastatin is also ...
ATLANTA (Reuters) - Adding a drug that lowers blood fats known as triglycerides to cholesterol-fighting statins provided no additional protection from heart attack, stroke and death from heart disease in patients with Type 2 diabetes, according to data from a large study. ...
ATLANTA (Reuters) - Adding a triglyceride-lowering drug to cholesterol-fighting statins provided no additional protection from heart attack, stroke and death from heart disease in patients with Type 2 diabetes, according to data from a large study. The study run by the National ...
Federal regulators have granted AstraZeneca approval to market its cholesterol pill Crestor as a preventive measure against heart attack and stroke in patients with healthy cholesterol levels. The Food and Drug Administration decision will allow the company to promote Crestor to millions ...
There's no evidence Merck & Co.'s blockbuster cholesterol drug Vytorin causes cancer, federal regulators said Tuesday. They reviewed reams of data after a patient study last year raised suspicions of a link, weakening sales already hurt by questions about the drug's efficacy. ...
WASHINGTON (Reuters) - U.S. regulators see benefits to using an AstraZeneca Plc cholesterol drug in a vast new group of patients but will ask outside advisers to probe various safety issues, documents released on Friday said. AstraZeneca wants permission to promote the ...
FDA says cholesterol pill Crestor curbs heart problems in patients, but notes diabetes riskFederal scientists say AstraZeneca's cholesterol pill Crestor lowers the risk of heart attack, death and stroke in patients without a history of heart disease, though some safety concerns remain. ...
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Allergan Settlement
Food and Drug Administration (FDA) Commissioner Margaret Hamburg, center, with Assistant Attorney ...AP News - -
US Allergan Settlement
Food and Drug Administration (FDA) Commissioner Margaret Hamburg speaks to reporters during ...AP News - -
Cymbalta FDA Review
FILE - In this Jan. 25, 2006 file photo, a production technician at ...AP News -
From Around the Web
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