Pink Sheet is part 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

Industry/Agency Revolving Door Hits Spear In Nose, But Firm Relaunches ANDA

Executive Summary

While Spear's generic fluorouracil is back on the market after a temporary restraining order expired June 18, the odyssey illustrates the risks to companies inherent in FDA relying on industry opinions during product review

You may also be interested in...



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

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.

Generic Eloxatin Suspension Makes At Risk Launches A Little Riskier

Teva and Hospira halt shipments of oxaliplatin after an appeals court temporarily stays FDA approval of their ANDAs.

Citizen Petition Changes In FDAAA Force Firms To Reconsider Timing Strategy

Legislative changes to the citizen petition process are forcing would-be petitioners to reevaluate when they should submit their petitions to the FDA

Related Content

UsernamePublicRestriction

Register

PS049814

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