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

FDA’s OGD Takes Fight To COVID-19 With Half-Century Of Approvals

Six-Dozen First Generics Approved Last Year Including $3.3bn Tecfidera

Executive Summary

The sixth annual report of the FDA’s Office of Generic Drugs covered a year dominated by the novel coronavirus pandemic – although first-time generic approvals and record levels of communication also featured prominently.

You may also be interested in...



Milla Follows Sandoz Partnership With Shortage-Hit Sodium Acetate Launch

Milla Pharmaceuticals, part of the Alter Pharma Group, toasted three milestones as it announced approval and launch of its generic version of Pfizer’s sodium acetate 2mEq/ml injectable in the US.

Teva Identifies ‘Problem Pattern’ Of Complex CRLs Ahead Of GDUFA III

Forecasting up to a dozen complex generic launches by Teva in the US in 2021, executive vice-president for North America commercial Brendan O’Grady said Teva was continuing to push for changes to boost approval rates ahead of GDUFA III next year.

Slayback Exclusivity On Taytulla Does Not Bar Rival ANDA Product

Slayback Pharma has now launched its Merzee generic version of Allergan’s Taytulla oral contraceptive with a CGT designation, several months after Xiromed moved first.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

GB150678

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