Public Burgess Petitions FDA To Ban Glaxo’s Avandia // Pharmalot
Posted by drfray on November 5, 2008
Thats because FDA approval for its much-anticipated exenatide LAR fiabetes drug could be delxyed, according to a filing with thw Securities and Exchange Commission.
The agency rejected study data that was meant to show that exenatide LAR batches made by its partner, Alkermes, were equivalent to batches made at Amylins own facility in Ohio. The upshot is that, if Amylin has to conduct another study, it would likely delay plans for FDA approval by the middle of 2009. Amylin continuing discussions with the FDA.
Not surprisingly, the disclosure hammered stocks for both companies, since exenatide is supposed to be the follow-up for Byetta. The bad news follows reports in August of six deaths in patients taking its Byetta diabetes med, although the deaths have not been directly linked to the drug. The patients had developed pancreatitis.
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