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’s EpiPen Defense Against Generics Focuses On Device Design

This article was originally published in The Pink Sheet Daily

Executive Summary

Mylan wants Teva to conduct comparative studies of its epinephrine auto-injector and to resubmit its ANDA as a 505(b)(2) NDA; citizen petition includes declaration from former FDA advisory committee member.

You may also be interested in...



Teva To Launch First Generic EpiPen In 'Coming Months'; FDA Heralds Approval Of Complex Product

Two-and-a-half years after receiving a complete response letter, Teva's ANDA clears FDA; agency issued three guidances for development of generic epinephrine auto-injectors.

Teva To Launch First Generic EpiPen In 'Coming Months'; FDA Heralds Approval Of Complex Product

Two-and-a-half years after receiving a complete response letter, Teva's ANDA clears FDA; agency issued three guidances for development of generic epinephrine auto-injectors.

EpiPen Generics: Woodcock Explains Injector Studies

In response to Congressional questions about whether FDA is a barrier to competition for the epinephrine product, CDER Director lays out what could be required to prove an injector device problem is fixed.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS077801

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