NEW YORK, Feb 25 (Reuters) – Due to weather-related delays, U.S. regulators will need an additional five days to act on a marketing application filed by Amylin Pharmaceuticals Inc and Eli Lilly and Co for a once-weekly form of their diabetes drug Byetta, the drugmakers said. Amylin and Lilly on Thursday said the U.S. Food and Drug Administration has set a new action date of March 12 for the …
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The Food & Drug Administration (FDA) is requiring Amylin Pharmaceuticals to conduct more safety studies of its type 2 diabetes drug, Byetta.
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Amylin and Eli Lilly have announced that the U.S. Food and Drug Administration has implemented label changes for Byetta which is indicated for the treatment of type II diabetes.
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The FDA has announced labeling changes on the diabetes drug BYETTA (exenatide). The revisions will warn doctors and patients of the risk of kidney failure and renal insufficiency when taking the medication.
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A commonly used drug to treat Type II diabetes, Byetta, has come under the scanner of the US Food and Drug Administration (FDA), which says that it causes kidney problems including kidney failure in patients.
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