FDA rejects Byetta data

Published: Nov. 6, 2008 at 12:04 AM

WASHINGTON, Nov. 6 (UPI) -- The U.S. Food and Drug Administration has rejected research data for a long-acting version of the diabetes drug Byetta.

The FDA rejected Eli Lilly's studies comparing small-scale batches of Byetta LAR made by partner Alkermes to large-scale batches made at an Amylin Pharmaceuticals manufacturing plant, Amylin said. Conducting a new study could delay the company's plans to seek approval next year, the Indianapolis Star reported.

The version of Byetta currently on the market is a twice-a-day injectable drug to help diabetics control their blood sugar, the newspaper said.

© 2008 United Press International, Inc. All Rights Reserved.
Order reprints



Additional News Stories
UPI Sports Calendar for Tuesday, Nov. 24 (28 min)
Hiring rivals' workers can be an advantage (37 min)
NBA: Los Angeles Clippers 91, Minnesota 87 (60 min)
Tea may help control blood sugar
COL BKB: Maryland 79, Chaminade 51
NHL: Anaheim 3, Calgary 2 (SO)
COL BKB: Texas 85, Iowa 60
fark
Charges dropped against dad who drove a drunken intruder away from his wife and young kids... with...
The Public Option, which was alive, then dead, then alive, then dead, then alive, then dead, then...
If you are the person who stole more than 1,000,000 bees, please return them as it is nearly pollination...
Caption President Obama and his staff overlooking a computer
Scottish city declines to sanction official drunken street party for New Year's, since citizens...
Recent immigrants to Canada more likely to be male, younger, better educated, work for smaller companies...