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.

Menu

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
Menu
My View
  • Edit
  • Add your favourite topics for quick access
Meet the Team
Ask the Analyst
Partnered Content
PDF Library
RSS Feeds
Subscribe
Advertising
Report Store
UsernamePublicRestriction
Tags:
BioPharmaceutical Regulation Approvals

More Bad News For Pozen: Another Delay To Market For Yosprala

This article was originally published in The Pink Sheet Daily

  • News

Executive Summary

The company received a second “complete response” letter from FDA for Yosprala, its fixed-dose combination of aspirin and omeprazole, due to issues with the undisclosed third-party supplier.

You may also be interested in...



Keeping Track: Opdivo Dosing Simplified; Yosprala, Cuvitru Approved; Telotristat Review Lengthened

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

Approval Might Be The Least Of Aralez's Challenges With Yosprala

If the aspirin/omeprazole finally gets approved on its third FDA review, Aralez then will face the challenge of positioning a prescription product against generic, over-the counter versions of both of its main components.

Sandoz Optimistic On Biosimilars As It Reprioritizes US Portfolio

Sandoz US president Carol Lynch talked to Scrip about its changing US portfolio, which will emphasize biosimilars, as the Novartis unit is poised to divest most of its US generics portfolio to Aurobindo.
Table

View full table

Topics

Related Companies

Related Deals

Tags:
BioPharmaceutical Regulation Approvals
UsernamePublicRestriction

Register

PS076750

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

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