Generics Bulletin 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 Submissions Continue Yo-Yo Pattern, Unlike Approvals

Executive Summary

After spike in March, generic drug application submissions drop 62% in April, while approval volume remains at monthly average.

You may also be interested in...



Generic Drug Puzzle: Why Did ANDA Submissions Spike Again?

Jump in March may have been "happenstance," but also could be concerning as US ANDA submissions reach near record pace.

ANDA Stress Test: End-Of-Year Submission Bolus Pressures US FDA Review System

As more generic applications arrive, Office of Generic Drugs staff may have a tougher time reaching review goals.

Another ANDA Submission Surge Begins

US FDA receives more than 100 ANDAs during the first month of GDUFA year five, suggesting sponsors want the new 10-month review goal and cheaper user fee.

Related Content

Topics

UsernamePublicRestriction

Register

GB002205

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