News tagged with fda

FDA panel again rejects wider use of J&J's Xarelto

A panel of Food and Drug Administration experts again opposed expanding use of Johnson & Johnson's blood thinner Xarelto to reduce dangerous blood clots in a new group of patients, those with acute coronary artery disease.

Jan 16, 2014
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States urged to register compounding pharmacies

The federal government has sent letters to states and other stakeholders across the country calling on them to encourage compounding pharmacies to register as a producer of sterile drugs in an effort to protect the public.

Jan 10, 2014
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US health watchdog rejects Sanofi's MS drug

French drug giant Sanofi announced Monday US health authorities had rejected its Lemtrada drug for some forms of multiple sclerosis, which is already approved in the European Union, Canada and Australia.

Dec 30, 2013
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Tretten approved for genetic clotting disorder

(HealthDay)—Tretten (coagulation factor XIII A-Subunit recombinant) has been approved by the U.S. Food and Drug Administration to treat a very rare blood clotting disorder called congenital Factor XIII A-Subunit deficiency.

Dec 23, 2013
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FDA introduces new food defense rule

(HealthDay)—A new rule to protect the nation's food supply from terrorism has been introduced by the U.S. Food and Drug Administration, the agency announced Friday.

Dec 21, 2013
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