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 New PSG Batch Features GSK’s Inhalers

New Guidance Documents Issued on HIV, ALS, Oncology, And Opioid Overdose Generics

Executive Summary

In its latest batch of product-specific guidances, the FDA released multiple new and revised guidances on inhalers, including several on GSK’s products such as Relenza and the Ellipta trio.

You may also be interested in...



US Senator Calls Out Big Pharma Over Improper Inhaler Patents

US Senator Baldwin’s letters to four inhaler manufacturers come after the FTC challenged their patents last year, but the companies rejected patent amendment claims.

FDA’s Latest PSGs Include Wegovy Generics

A fresh batch of product-specific guidances to aid generics development has been published by the US Food and Drug Administration, including new documents covering Wegovy, Duobrii and Radicava ORS, as well as revised PSGs for Celestone Soluspan and Gralise.

AstraZeneca Rejigs Respiratory Franchise With Fresh Covis Deal

Having got hold of two COPD drugs from Spain's Almirall in 2014, AstraZeneca has passed Eklira and Duaklir onto old partner Covis Pharma as it focuses on more targeted respiratory therapies.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

GB153312

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