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
UsernamePublicRestriction

US FDA Releases Slew Of Guidances On A Fell Day For Complex Generics

Executive Summary

New and updated guidances are good news for ANDA sponsors, but timing – coming the day Sandoz announced a CRL for its Advair copy – underscores challenges that developers of complex generics face.

You may also be interested in...



For Novartis' Generic Advair, Another 18 Months Was Too Far Into The Unknown

Company did not kill its development program because of US FDA feedback, but the experience seems to be another lesson in the difficulty in gaining approval for complex generics.

Gottlieb On Pursuing Legislative Reform: Start Small, Build Later

Former US FDA commissioner Scott Gottlieb encouraged stakeholders at the Association for Accessible Medicine's GRxBiosims 2019 meeting to start small in scope when pushing for legislative changes, which makes it easier to build on later.

Keeping Track: FDA Approves First Generic Advair, But Alkermes And Sunovion Land CRLs

The latest drug development news and highlights from our US FDA Performance Tracker.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

LL1133951

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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