In Vivo 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 Prioritizes Reviews Of Opioid Overdose ANDAs

Executive Summary

Opioid overdose treatments containing naloxone or nalmefene are now eligible for expedited ANDA review in a bid by the FDA to improve patient access.

You may also be interested in...



Hikma Snaps Up Insys Sprays As Part Of US Drive Towards Differentiation

By acquiring global rights to epinephrine and naloxone nasal spray candidates from Insys, Hikma is following its strategy of moving its non-injectable Generics business segment in the US towards differentiated products.

OTC Naloxone's Potential Overshadowed As FDA Priortizes Rx Generic Reviews

FDA appears committed to stemming opioid abuse by accelerating reviews of ANDAs for generics of overdose treatments but acceleration for making one of them, naloxone, available OTC is needed, too, says Michael Hufford, Harm Reduction Therapeutics CEO. "Relief that ... FDA is demonstrating its willingness to do everything that it can to accelerate these approvals," but "frustration that the public continues to be denied access to low cost naloxone," he says.

FDA Adds Transparency On Paragraph IVs In Bid To Spur Competition

By disclosing when the first paragraph IV patent challenges were filed, how many players are in the race, and whether it has decided on eligibility for 180-day exclusivity, the FDA is aiming to spur greater competition in the US generics arena.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

GB140489

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