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On scan days, baseline scans were followed by intravenous administration of nicotine at a dose equivalent to the nicotine delivered by 1.5 cigarettes.
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Although it is sold over-the-counter, melatonin isn't approved by the Food and Drug Administration and researchers disagree on the optimal dose.
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Both El-Masri and Milani say the U.S. Food and Drug Administration should keep a close eye on the top dose of Zocor.
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Yesterday the Food and Drug Administration told doctors to stop prescribing the top 80-milligram dose of simvastatin, also known by the brand name Zocor, to new patients because of a heightened risk of muscle pain.
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The Food and Drug Administration instituted the new limit on the top 80-milligram dose of Zocor, generically known as simvastatin because that dose has been associated with an elevated risk of muscle injury, which can lead to potentially dangerous consequences.
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The U.S. Food and Drug Administration today approved Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously approved medicines in one tablet for use in adults who need both sitagliptin and simvastatin.
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According to Lieberman, the investigators approached the makers of all the drugs being used in CATIE with proposed dose ranges that went above what the U.S. Food and Drug Administration had approved.
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Merck withdrew the 160-milligram top dose of Zocor from consideration at the U.S. Food and Drug Administration, Nissen writes, because of muscle-weakening side effects, which it may have caused more than 5% of the time--data that was not publicized.
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