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New Prozac Labels Approved

The Food and Drug Administration approved new labels Thursday for the antidepressant Prozac that spells out how well the drug works on people age 65 and older.

The FDA approval comes in the wake of a 1997 FDA ruling requiring medications to have a "Geriatric Use" section in their labeling with information about how the drugs work with elderly patients.

Lilly submitted Prozac for the new labeling about a year ago, said Lilly spokesman Greg Kueterman.

"They agreed to allow us to put information that confirms the safety and effectiveness of this drug," said Kueterman. "We think that this will give physicians even more confidence and a greater comfort level when they're treating elderly depressed patients."

Before the label change was approved, the label on Prozac containers "said something to effect of 'not enough information,"' Kueterman said.