According to the FDA memo (found at the FDA website; www.fda.gov), dated January 27, 2012, the approval of Bydureon, which has the same active ingredient as Byetta, was long and complicated, "in part due to Amylin's withholding of information on Byetta that FDA deemed to be important to its evaluation of the safety and effectiveness of Bydureon."
When Amylin applied for approval of Bydureon it requested that FDA use the safety and efficacy findings from Byetta trials, which the FDA agreed to do. But the FDA says it was not made aware of a "thorough QT [tQT] study" conducted for Canadian authorities. That study, the FDA notes, raised concerns for Health Canada, which lead to approval of Bydureon being delayed. Health Canada notified the FDA of the study, which the FDA then confirmed with Amylin.
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Mary Parks, the FDA division director who wrote the memo, further noted that despite the FDA requesting information from the tQT study be included in a resubmitted Bydureon application, Amylin did not comply, sending the info as an addendum to the Byetta file instead of as part of the Bydureon application.
Bydureon is a once-weekly version of Byetta. It was approved for use in January 2012, after a lengthy approvals process that included the drug being denied approval twice.
Byetta has been linked to serious side effects that resulted in the FDA issuing two safety alerts. The alerts, released in October 2007 and August 2008, warned about the risk of pancreatitis, including necrotizing or hemorrhagic pancreatitis.