Home
July 2008 August 2008 September 2008
Su Mo Tu We Th Fr Sa
Week 31 1 2
Week 32 3 4 5 6 7 8 9
Week 33 10 11 12 13 14 15 16
Week 34 17 18 19 20 21 22 23
Week 35 24 25 26 27 28 29 30
Week 36 31

Lilly Gets Conditional Approval of Duloxetine for Urinary Incontinence Show Comments PDF Print E-mail
Wednesday, 03 September 2003
NEW YORK (Reuters) - Eli Lilly and Co. said on Wednesday it received conditional regulatory approval for its treatment for stress urinary incontinence, casting some doubt on when the same drug, Cymbalta (duloxetine), might get clearance for depression.

NEW YORK (Reuters) - Eli Lilly and Co. said on Wednesday it received conditional regulatory approval for its treatment for stress urinary incontinence, casting some doubt on when the same drug, Cymbalta (duloxetine), might get clearance for depression.

The company said the Food and Drug Administration did not disclose how its requests for further information for the incontinence treatment might affect the review and approval process of Cymbalta.

Conditional approvals, though encouraging, often cause a significant delay in bringing a new drug to market.

While there is some uncertainty about the timing of approval for stress incontinence, analyst Robert Hazlett of SunTrust Robinson Humphrey said, two separate divisions of the FDA are reviewing the drug for the different treatments, which can have "separate approvability criteria."

Lilly said it expects final approval for duloxetine in late 2004 or the first half of 2005 for stress urinary incontinence.

The company said final FDA approval of the drug for this condition depends upon successful completion of additional pharmacology studies, resolution of manufacturing issues at Lilly's Indianapolis plants and completion of label negotiations.

Plant problems, including deficiencies in data handling and the manufacturing review process, have delayed approval of key Lilly drugs, including Cymbalta, over the past two years.

The company said it would work rapidly to provide the additional data and resolve the manufacturing issues.

(Additional reporting by Jed Seltzer).


Copyright © 2003 Reuters Limited. All rights reserved. Republication or redistribution of Reuters Limited content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters Limited. Reuters Limited shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Reader Comments

Please log-in or register in order to submit comments.

Powered by AkoComment!

 
User Rating: / 0
PoorBest


 
< Prev   Next >