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

2000 NDA approvals

This article was originally published in The Tan Sheet

Executive Summary

FDA approved 160 new drugs and devices in 2000, a Jan. 18 "Talk Paper" states. Agency specifically notes McNeil's Motrin, Whitehall-Robins' Advil, Pfizer/Warner-Lambert's Zantac 75 and Pharmacia's Nasalcrom added pediatric information to their labeling during the year. CDER approved 98 NDAs last year with an average approval time of 15 months. The center's 15-year high for NDA approvals was 1996, when it approved 131; its fastest average NDA approval times were seen in 1998 (12.8 months)
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS092092

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