Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Advertise
  • SUBSCRIBE

FDA Approves 8-Week Storage of Prostate Cancer Injectable at Room Temperature

By PR Newswire | May 6, 2016

TOLMAR Pharmaceuticals, Inc., announced that approval has been received from FDA for a label update for ELIGARD®, indicated for the palliative treatment of advanced prostate cancer. Stability studies demonstrated that, prior to mixing, ELIGARD may be stored at room temperature (59 – 86° F) for up to 8 weeks following removal from refrigeration. ELIGARD is the only LHRH (luteinizing hormone releasing hormone) agonist with the innovative, controlled-release ATRIGEL® Delivery System.

“The results of our stability studies and subsequent FDA approval of the label update provides practices greater flexibility for storage and administration of ELIGARD for their patients with advanced prostate cancer,” said Stuart Atkinson, MB ChB, Vice President and Head of Medical Affairs for TOLMAR Pharmaceuticals, Inc.

ELIGARD is a luteinizing hormone-releasing hormone (LHRH) agonist designed to reduce the amount of testosterone in the body by reducing its production. It is the only LHRH agonist available via subcutaneous injection with the innovative, controlled release ATRIGEL Delivery System. ELIGARD is available in 1-,3-,4-, and 6-month doses.

 “At TOLMAR Pharmaceuticals, we are dedicated with purpose to advance ELIGARD with science and data as our focus. These new stability data, together with updated storage and administration labeling, demonstrate our continued commitment to meeting the needs of healthcare professionals and patients,” said Susan Rodriguez, CEO of TOLMAR Pharmaceuticals”.

Follow us on Twitter and Facebook for updates on the latest pharmaceutical and biopharmaceutical manufacturing news! 

Related Articles Read More >

Doctor, woman patient and tablet for consulting with results, medical info and talk for healthcare with mockup space. Japanese medic, digital touchscreen or show video for surgery, wellness or advice.
Putting patients first in clinical trials
Confidently navigate the transition from bench to batch
Merck
FDA approves Merck’s Winrevair to treat pulmonary arterial hypertension
kobayashi pharmaceutical logo
Report: Japan health authorities investigate Kobayashi Pharmaceutical factory after five deaths
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

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.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 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
  • Advertise
  • SUBSCRIBE