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

FDA New Drug Approval Count May Fall Back To Earth In 2016

Executive Summary

A repeat of FDA’s record-breaking NME approval performance from recent years looks unlikely, even though the 14 novel approvals in the first half of 2016 equals the first half total for 2015, because almost one-third fewer novel candidates have user fee goals in the second half.

You may also be interested in...



Do FDA Submission, Approval Declines Outside Cancer Signal Future Treatment Gaps?

Outlining a "fairly substantial decline in the number of non-oncology NMEs approved compared to last year" plus downward trend in applications, US FDA's Jenkins underscores continued "tremendous needs" for primary care products.

What Goes Up … US FDA Expects 2016 NME Approval Total To Come Down

After a record-setting 2015 for new drug approvals, there were not enough applications with user fee goals in 2016 to reach that level again.

Perrigo Hopes Esomeprazole Helps Make Private Label OTCs A Bright Spot

The firm lowers its 2016 guidance as its European branded OTC drug and nutritional product business and its Rx topicals business appear to be major obstacles to escaping its earnings slump.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS118777

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

Cancel