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

ANDA Approvals Break Record, May Set New Normal

Executive Summary

FDA's June approval total is highest of GDUFA era, but does it signal a new elevated productivity level for the generics program?

You may also be interested in...



Is Bloom Gone From Rosy ANDA Approvals Figures?

US FDA sets a new monthly record for full approvals, but industry group argues that approvals alone aren't creating more generic competition in the market.

Is Bloom Gone From Rosy ANDA Approvals Figures?

US FDA sets a new monthly record for full approvals, but industry group argues that approvals alone aren't creating more generic competition in the market.

Gottlieb's 2018 Generic Drug Approval Goal May Be In Doubt

Thanks in large part to new elemental impurities requirements, ANDA approvals are behind the pace needed to beat 2017’s record.

Related Content

Topics

UsernamePublicRestriction

Register

PS121066

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