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# FDA OKs Tolmar NDA Supplement for Eligard
- URL: https://www.fdaweb.com/fda-oks-tolmar-nda-supplement-for-eligard/
- Published: 2016-05-06T12:00:00.000Z
- Updated: 2026-09-14T21:00:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135591

FDA has approved a Tolmar Pharmaceuticals NDA supplement to update the label for Eligard (leuprolide acetate for injectable suspension), indicated for the palliative treatment of advanced prostate cancer. The update covers drug stability data that show, prior to mixing, Eligard may be stored at room temperature (59 – 86° F) for up to eight weeks following removal from refrigeration. The luteinizing hormone-releasing hormone (LHRH) agonist is 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,” according to the company.