Posted by SLS on July 17, 2003, at 8:26:26
Cymbalta (duloxetine)
NEW YORK, June 11 (Reuters) - Eli Lilly and Co (NYSE: LLY - nyheder) . said on Wednesday it is on track to launch its new depression drug this year following recent plant inspections by U.S. regulators, and that second-quarter earnings should hit the high end of its earlier estimates.Shares of the Indianapolis drug maker, which needs new products to pull itself out of a two-year earnings slump, rose as much as 5 percent after the two announcements.
Lilly said in April that approval of the depression treatment, Cymbalta, hinged on successful re-inspections by the U.S. Food and Drug Administration of the Indianapolis plant where it is made.
Lilly spokesman Rob Smith said the FDA inspected the plant on May 5. While the company may need to take additional steps to satisfy the agency's quality-control requirements, he said it still expects U.S. approval of Cymbalta by the fourth quarter.
"We interpret the completion of the reinspections and Lilly's reiteration of earnings guidance as a positive," said Prudential Financial (NYSE: PRU - nyheder) analyst Tim Anderson, who speculated the FDA may actually clear Cymbalta before the fourth quarter.
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thread:242797
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