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's Decision-Making Process For ANDA Approval Standards Questioned In Vancomycin Case; Would Process Changes Alter The Outcome?

Executive Summary

ViroPharma has fired another shot across FDA's bow in the continuing battle over approval standards for generic oral vancomycin, charging in a petition supplement that the Office of Generic Drugs' decision to change bioequivalence methods for this antibiotic "was fraught with irregularities.
Advertisement

Related Content

Lipitor Generics: FDA Says Mylan Has No Standing To Sue (Until June 28?)
Lipitor Generics: FDA Says Mylan Has No Standing To Sue (Until June 28?)
Follow-On Biologics One Possible Fruit Of FDA-Northeastern Collaboration
Follow-On Biologics One Possible Fruit Of FDA-Northeastern Collaboration
Generic Approval Standards For Vancomycin Tightened In FDA Draft Guidance
Industry/Agency Revolving Door Hits Spear In Nose, But Firm Relaunches ANDA

Topics

Advertisement
UsernamePublicRestriction

Register

PS051931

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