Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards

Halozyme Completes Hylenex Manufacturing Probe(2)

By Pharmaceutical Processing | August 31, 2010

SAN DIEGO (AP) — Halozyme Therapeutics Inc. has completed an investigation into manufacturing problems behind its Hylenex product and has drawn up a corrective action plan and strategy to reintroduce it to the market.

Hylenex is used to help the body increase the absorption of fluids, in order to boost injected drugs and to increase the absorption of fluids and drugs administered under the skin. The drug was launched in the United States in 2009 for use in pediatric rehydration.

In May, Baxter International Inc. voluntarily recalled all lots of Hylenex because of glass particles found in vials of the product. Baxter, based in Deerfield, Ill., makes Hylenex for San Diego-based Halozyme.

To date, no adverse medical events have been reported in connection with the withdrawn Hylenex product.

Halozyme and Baxter are completing materials for a meeting with the Food and Drug Administration over the reintroduction strategy. Halozyme said it has lifted the breach notice it sent Baxter in May.

 

Related Articles Read More >

Pfizer logo
Pfizer seeks to comply with voluntary Net-Zero Standard by 2040
Fujifilm Diosynth Technologies
Fujifilm to spend $1.6B to bolster cell culture manufacturing services
Wyzo
Wyzo high-speed pick-and-place sidebot wins design awards
Purdue University
Purdue University launches institute for advanced manufacturing of pharmaceuticals

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Pharmaceutical Processing news in a minute?

We Deliver!
Pharmaceutical Processing Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Pharmaceutical Processing World
  • Subscribe to Our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards