On August 10, 2020 Tolmar Pharmaceuticals, Inc., a specialty pharmaceutical company, reported the full availability of ELIGARD (leuprolide acetate) for injectable suspension in all doses for patients undergoing palliative treatment for advanced prostate cancer (Press release, Tolmar Pharmaceuticals, AUG 10, 2020, View Source [SID1234563373]). The company confirmed the complete inventory of product supply and also announced a production increase in response to reports of a shortage in the United States for a different leuprolide acetate injection product used in the palliative treatment for advanced prostate cancer. Tolmar has a demonstrated record of providing consistent supply of ELIGARD in the U.S. and globally across approximately 89 countries, with no shortages to date.

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On July 24, 2020 and re-verified on August 3, 2020, the U.S. Food and Drug Administration (FDA) listed the Lupron Depot, 3 months, 22.5 mg PDS Kit and 6 months, 45 mg PDS Kit as not available and on backorder in its database of Current and Resolved Drug Shortages and Discontinuations Reported to FDA. The listing indicates the estimated duration of this shortage is currently unknown.

"Tolmar is pleased to step up production in our state-of-the-art cGMP facilities to help ensure that advanced prostate cancer patients across the U.S. won’t miss a single injection in their treatment plan," said Anil D’Souza, Chief Executive Officer, Tolmar. "ELIGARD has always been manufactured to the highest quality standards in our Northern Colorado plants, and we are able to fill any short or long-term gaps in the supply of this drug for those who need it."

ELIGARD (leuprolide acetate) for injectable suspension, an FDA-approved palliative treatment for advanced prostate cancer, is given by subcutaneous injection. It is a form of androgen deprivation therapy, which is the standard of care for the treatment of advanced prostate cancer. A luteinizing hormone-releasing hormone (LHRH) agonist, ELIGARD reduces circulating testosterone to castration levels to inhibit the growth of cancer cells. It may be administered monthly or in three, four or six-month controlled-release doses. All doses are in inventory.

"During the global COVID-19 pandemic, cancer patients, providers and others in the urology and uro-oncology community should not have an added concern about the supply of a vital medication," continued Mr. D’Souza. "Tolmar has a full inventory of API and the other components of ELIGARD, and the capacity to manufacture sufficient supply of the drug for those who need it at this time."

For more information about product availability or any questions about reported leuprolide acetate product shortages in the U.S. market, please contact Tolmar at 1-877-ELIGARD (1-877-354-4273).