Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

FDA Bioequivalence Study On Metoprolol Shows Emerging Generic Investigation Strategy

This article was originally published in The Pink Sheet Daily

Executive Summary

Outside research project launches after FDA does not find a safety signal in its internal investigation into generic versions of AstraZeneca’s Toprol XL.

You may also be interested in...



Sentinel May Expand To Generic Equivalence Studies

Tool being designed for rapid queries of US Sentinel data to consider generic drug switches, potentially spot equivalence problems.

Sentinel May Expand To Generic Equivalence Studies

Tool being designed for rapid queries of US Sentinel data to consider generic drug switches, potentially spot equivalence problems.

Watson’s Bupropion XL Undone By Outlier Patient, Bankrupt CRO

After long delay, FDA quietly reveals second Wellbutrin generic deemed not therapeutically equivalent; ex-Office of Generic Drugs official predicts FDA will tighten criteria for extrapolating data to higher generic strengths.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS077291

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. 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