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


Second Consecutive Year Of Growth In NME Approvals In The Cards For FDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

It looks to be a good bet that 2009 will mark a second year of growth in new drug approvals as FDA enters the second half of the year with a robust first-half NME approval tally and a well-stocked pipeline of novel agents with user fee goal dates in the remaining months of the year.

You may also be interested in...

New Molecular Entities Approved In 2010


Surrogate Endpoints Don't Convince ODAC: Panel Votes No On Two Centocor/Ortho Biotech Drugs

ODAC votes 14-1 against Yondelis in combination with Doxil for ovarian cancer, and 13-0 against Doxil in combination with docetaxel for metastatic breast cancer.

Future Highlights? Novel Products With User Fee Goals In The Second Half Of 2009

Related Content





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