Generics Bulletin 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

Hyloris Submits Additional Data For Maxigesic IV Filing To US FDA

Firm Received Pushback From FDA On Product’s Packaging

Executive Summary

Hyloris has submitted additional data to the US Food and Drug Administration about its value-added analgesic Maxigesic IV, following enquiries about potential extractable and leachable compounds expected to be present in the product due to the packaging.

You may also be interested in...



Hikma Launches Combined Pain Relief Drug Combogesic IV In US

Hikma announced the launch of the pain relief solution in the US where it will be sold under the name Combogesic IV as part of a deal with Hyloris Pharmaceuticals.

Hyloris And Hikma Get Maxigesic IV Approval In US

Hyloris has announced US FDA approval for its Maxigesic IV innovative paracetamol/ibuprofen solution for infusion. The product is expected to launch in the US in early 2024 via marketing partner Hikma, under the name Combogesic IV.

Hyloris Lines Up Hectic Year Of Clinical Trials And Major US Launch

Hyloris has an eventful year ahead as it plans to conduct numerous trials for products in its ever-expanding pipeline and launch Maxigesic IV in the US.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

GB152663

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