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FDA OKs REMS for Fentora, Actiq
FRAZER, Pa. — The Food and Drug Administration has approved a risk evaluation and mitigation strategy for two painkillers made by Cephalon, the drug maker said Thursday.
The FDA approved a REMS for Fentora (fentanyl) buccal tablets and Actiq (oral transmucosal fentanyl citrate). Both drugs are used for managing breakthrough pain in cancer patients who have become tolerant of opioid drugs.
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Brilinta receives FDA approval
WILMINGTON, Del. — The Food and Drug Administration has approved a drug made by AstraZeneca to reduce the rate of heart attacks in patients with acute coronary syndrome, the Anglo-Swedish drug maker said.
AstraZeneca announced the approval of Brilinta (ticagrelor), a blood-thinning drug, on Wednesday. The drug maker is touting the drug as an alternative to Plavix (clopidogrel), made by Sanofi and Bristol-Myers Squibb.