The FDA Approves ELIGARD (leuprolide acetate for injectable suspension) Storage at Room Temperature for up to 8 Weeks

Approval has been received from the 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”

 

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