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INDIANAPOLIS — Drug makers Eli Lilly, Amylin Pharmaceuticals and Alkermes are giving their long-acting form of an injected drug for Type 2 diabetes another try at the Food and Drug Administration.
The three companies announced Thursday that they had submitted an official reply to the FDA, concerning the agency's decision to not approve Bydureon (exenatide), an extended-release version of the drug Byetta. In October, the FDA delivered a complete response letter to the companies, meaning that it had completed review of the original regulatory application, but questions remained that precluded final approval.
The companies expect to receive a response from the FDA in the next two weeks, while review could take up to six months.