Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Tidbits From First Quarter Conference Calls, In Brief

Executive Summary

GSK Wellbutrin SR generics: Difficulty in manufacturing Wellbutrin SR likely to stall generic competition for bupropion extended-release, GlaxoSmithKline CEO J.P. Garnier says April 30. "This product is not that easy to copy. In fact, the SR is a fraction easier; the XL is really tough." Blend uniformity problems have prevented approval of Andrx' ANDA; those issues are said to have been resolved (1"The Pink Sheet" July 15, 2002, p. 7)....Andrx bupropion delay: Andrx is "communicating" with FDA regarding a specification change that affects expiration dating of its Wellbutrin SR generic, CEO Richard Lane says April 30. "Since learning of this issue, we have worked diligently to remedy the situation," he says. "We are unable to predict when and if this issue will be resolved satisfactorily and these products launched." Andrx is also awaiting D.C. court decision on GSK's appeal of non-infringement ruling (2"The Pink Sheet" Dec. 9, 2002, p. 28)....

You may also be interested in...



J&J Patches Together Strong Sales Growth With Ortho EVRA, Duragesic

J&J will step up promotion of Ortho EVRA in the fourth quarter, marking the end of supply constraints for the contraceptive patch

J&J Patches Together Strong Sales Growth With Ortho EVRA, Duragesic

J&J will step up promotion of Ortho EVRA in the fourth quarter, marking the end of supply constraints for the contraceptive patch

J&J Finalizing Risperdal Consta Resubmission; Approval Possible By Year-End

Johnson & Johnson is finalizing its response to a Risperdal Consta "not approvable" letter received from FDA last year

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS041750

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel