Tolmar announced that the Food and Drug Administration (FDA) has approved a label update for Eligard (leuprolide acetate for injectable suspension) for storage at room temperature (59–68ºF) for up to 8 weeks following removal from refrigeration based on data from stability studies.

Eligard, a luteinizing hormone-releasing hormone (LHRH) agonist, is indicated for the palliative treatment of advanced prostate cancer. It is the only LHRH agonist available as a subcutaneous (SC) injection that utilizes controlled-release ATRIGEL Delivery System. 

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Eligard works by decreasing the amount of testosterone in the body by reducing its production. Its administration results in an initial increase in circulating levels of LH and follicle stimulating hormone (FSH), leading to a transient increase in levels of the gonadal steroids (testosterone and dihydrotestosterone in males, and estrone and estradiol in premenopausal females).

Eligard is available as 7.5mg, 22.5mg, 30mg, and 45mg dosage strengths for 1-, 3-, 4-, and 6-month doses, respectively. It is supplied as a single-use kit of a 2 syringe mixing system. 

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