Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

FDA Revisits Wellbutrin Generics – Again; Will Teva Fund A High-Dose Study?

Executive Summary

As FDA considers how best to address continued concerns about generics for Wellbutrin XL (bupropion extended-release tablets), one issue it may wrestle with is whether it should conduct bioequivalence studies at the highest dose, 300 mg, which has a higher risk of seizures
Advertisement

Related Content

Generic Approval Standards For Vancomycin Tightened In FDA Draft Guidance
Generic Firms Object To Policy Behind Residual Solvents Deficiency Letters
Dingell May Tighten Inspection Provisions In Safety Bill, After Ranbaxy Alert
GMP Warning To Sandoz Questions Continued Lot Release; Will FDA Block It?
GMP Storm Cloud: Generic Firms May Get Further Scrutiny After Actavis Recall
Ranbaxy’s Ripples: Generic Drug Integrity Returns As Focus For Congress, FDA
Teva’s Generic Bupropion XL Meets Bioequivalence To Wellbutrin XL, FDA Finds
Editor’s Perspective: Is The Ketek Scandal Good For Big Pharma? Generic Biologic Bill Could Suffer
Federal Court Ruling Clears Way For Wellbutrin XL Generic
Biovail Sues FDA Over Wellbutrin XL Generics
Advertisement
UsernamePublicRestriction

Register

PS050143

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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