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


New Drug Approvals In 2003 Could Include Four HIV Agents

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA’s new molecular entity approval totals for 2003 could feature as many as four novel HIV agents.

You may also be interested in...

October NME User Fee Lineup Includes Solifenacin, Darifenacin

FDA has at least 28 pending applications with user fee deadlines in October, including seven NMEs and one new biologic.

FDA NME Tally: Spring Thaw Brings Three March Approvals

FDA closed the first quarter of 2003 with three new molecular entity approvals, all in March.

FDA Approval Is "First Action" For 32% Of NMEs; Rate Less Than Other NDAs

FDA approved approximately one-third of new molecular entities with user fee deadlines in 2002 on the first cycle.

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