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

FDA proposed antibacterial rule

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The agency proposed Sept. 19 that labeling for all systemic antibacterial drugs contain information about appropriate use of antimicrobials in order to help curb the emergence of drug-resistant bacterial strains. FDA Commissioner Jane Henney, MD, pointed out at a Sept. 20 Senate subcommittee hearing that Pharmacia's recently approved Zyvox (linezolid) "has some of this language in its package labeling." FDA is considering a drug exclusivity program to encourage microbial product development, which could be modeled after the agency's existing exclusivity program for orphan-designated drugs or pediatric products, she sai
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS001198

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