At a meeting of the FDA’s Pediatric Advisory Committee today, potential label changes will be considered for Eli Lilly’s antipsychotic drug Zyprexa. The Committee will evaluate whether new warnings are necessary about the risk of potential Zyprexa side effects for children, such as severe weight gain, hyperglycemia or other metabolic effects. Continued
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Concerns About Byetta Deaths Lead Amylin to Cut Work Force
Amylin Pharmaceuticals announced yesterday that they are cutting their work force by 25 percent following unexpectedly slumping sales for their once promising diabetes drug Byetta, which has recently been associated with 6 deaths caused by severe cases of pancreatitis. Continued
FDA Requires Additional Byetta Safety Data Before Considering Long-Acting Version
The FDA has rejected data submitted by Amylin Pharmaceuticals for a longer-acting Byetta, which will likely delay the new version of their diabetes drug. This is another blow to Amylin, which has seen their stock price plummet this year after Byetta was linked to fatal pancreatitis cases in August. Continued
Byetta Linked to Four More Pancreatitis Deaths
In a conference call late Monday, Eli Lilly & Co. and Amylin Pharmaceuticals, Inc. indicated that they have notified the FDA about four more deaths from pancreatitis among users of their diabetes drug Byetta. These four cases are in addition to two other Byetta pancreatitis deaths the FDA referenced in a notice to healthcare providers issued last week. Continued
