Pink Sheet is part of the Business Intelligence Division 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


Generic Combination Products May Be Permitted Delivery Device Variations

Executive Summary

But US FDA officials say brand vs. generic product differences won't be appropriate in all cases and patient misuse remains a concern.


Related Content

Keeping Track: Zelboraf Takes Breakthrough Path For Rare Blood Disease; Teva Resubmits Generic EpiPen
Mylan Suggests Downside To FDA's Efforts To Improve Generic Drug Review
FDA Drug Pricing Policy Offers Short-Term PR Gain, More Long-Term Actual Benefit
Breakthrough-Style Program For ANDAs Added To House User Fee Bill
Gottlieb Places Drug Pricing Out Front In First Speech To US FDA Staff
Advair Generic: Mylan Takes Issue With US FDA's 'Major' Concerns
Complex Generics: Gottlieb Eyes FDA Policy Changes To Speed Approvals
ANDAs For Drug/Device Combos Face High Bar At US FDA; Epipen, Advair May Benefit
Complex ANDAs To Be Allowed Pre-Submission Product Meetings
Mylan’s EpiPen Exclusivity Saved Again As Teva Reports CRL


Related Companies

Related Deals




Ask The Analyst

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

All set! This Question has been sent to 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