Generics Bulletin is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

US Approvals Off To A Slow Start

FDA Generic Drug Approvals Are Off To Slow Start In FY 2020

Executive Summary

US FDA reports another low tally of full approvals in October, but stakeholders are not worried given the agency's history of record-breaking totals year over year.

You may also be interested in...



FDA Breaks Record On Approvals

As the FDA breaks its record for generic drug approvals in fiscal year 2019, it emphasizes the importance of consumer confidence in the safety and quality of approved generics. 

Another US FDA Approval Record: ANDAs Set A New Annual High Mark In Only 10 Months

Office of Generic Drugs has granted full approvals to more than 800 ANDAs in fiscal year 2019, exceeding the previous mark reached in FY 2018.

Generic Drug Application Submission Downturn Continued In June

Approvals also plummeted, but US FDA remains on a record-breaking pace.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

GB149382

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