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

Mylan Sees A Difference In Having Generic Drug User Fees

Executive Summary

FDA is pushing forward with its review of Mylan’s ANDA for generic Advair, according to the company, which is gaining confidence that the application could receive a first round approval. The experience for that application, which has a generic drug user fee, is a clear contrast to the firm's experience with its pre-GDUFA Copaxone filing.

You may also be interested in...



Advair Generic: Mylan Takes Issue With US FDA's 'Major' Concerns

Dispute over analysis of inhaler device could delay launch of competitor to GSK's franchise until 2018; FDA's complete response letter to Mylan' deemed 'major.'

Advair Generic: Mylan Takes Issue With US FDA's 'Major' Concerns

Dispute over analysis of inhaler device could delay launch of competitor to GSK's franchise until 2018; FDA's complete response letter to Mylan' deemed 'major.'

Fate Of Copaxone 40mg Patents Depends On Courts After PTAB Rejection

Teva awaits district court ruling on patents covering the three-times-a-week dosage and is appealing the Patent Trial & Appeal Board’s findings of unpatentability.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS118939

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