Scrip 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
UsernamePublicRestriction

Otsuka Tries To Halt Alkermes Ride On Abilify’s Coattails

This article was originally published in PharmAsia News

Executive Summary

FDA should not review or approve Alkermes’ NDA for aripiprazole lauroxil because it is based on only one adequate and well-controlled clinical trial, Otsuka argues.

You may also be interested in...



Regulatory Briefs: Pradaxa’s New Indication, Lemtrada Resubmitted, New Hep C Drugs Under Review

Boehringer’s anticoagulant Pradaxa adds DVT/PE claim, coming closer to labeling parity with market leader Xarelto; Bristol gets in on the race for new oral hepatitis C drugs with daclatasvir/asunaprevir filings; Genzyme reaches agreement with FDA on resubmission plan for Lemtrada; and Alkermes prepares to file its long-acting aripiprazole lauroxil.

Alkermes Rides Into 2014 On Abilify’s Coattails

Building on its experience in long-acting injectables, Alkermes is preparing to file an NDA for its long-acting version of Otsuka/Bristol-Myers Squibb’s antipsychotic Abilify in 2014.

Off-Label Use: US FDA Backs Away From ‘Totality Of Evidence’ Standard In Proposed Reg

New proposed rule says a manufacturer’s knowledge of the unapproved use of a product does not alone determine intended use. Former FDA lawyer says rule could set off fireworks over the scope of what the agency considers evidence of off-label use.

Topics

Related Companies

UsernamePublicRestriction

Register

PS142970

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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