LINCOLNSHIRE, Ill., May 6, 2016 /PRNewswire/ -- TOLMAR Pharmaceuticals, Inc., today 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".
TOLMAR is a fully integrated pharmaceutical company focused on the development, approval, manufacturing, and commercialization of specialty pharmaceutical products. TOLMAR Pharmaceuticals is based in Lincolnshire, Illinois, with TOLMAR global headquarters, product development, and manufacturing facilities based in Fort Collins, Colorado. TOLMAR Pharmaceuticals has the exclusive distribution rights for ELIGARD in the US and Puerto Rico. ELIGARD is a gonadotropin releasing hormone (GnRH) agonist indicated for the palliative treatment of advanced prostate cancer, developed and manufactured by TOLMAR Inc. "TOLMAR" refers to TOLMAR Holding Inc. and its wholly owned operating subsidiaries, TOLMAR Inc., TOLMAR Therapeutics, Inc., and TOLMAR Pharmaceuticals, Inc.
Important Safety Information for ELIGARD® (leuprolide acetate for injectable suspension)
ELIGARD is a medicine for managing advanced prostate cancer. It is not a cure for advanced prostate cancer. ELIGARD should not be used by anyone who is allergic to any drug that is in the same class as ELIGARD, or anyone who is allergic to any of the ingredients in ELIGARD. A severe and possibly life-threatening allergic reaction called anaphylaxis has been known to happen when people receive ELIGARD and other drugs in its class. Women who are pregnant or may become pregnant should not use ELIGARD. ELIGARD can cause pregnancy loss or harm an unborn baby when used by a pregnant woman. Elevated blood sugar and an increased risk of developing diabetes have been reported in men receiving ELIGARD and other drugs in its class. Your doctor will monitor your blood sugar levels. Increased risk of heart attack, sudden death due to heart attack, and stroke also has been reported in men using drugs in ELIGARD's class. Your doctor will monitor you for heart disease. ELIGARD may also prolong the QT/QTc interval, which can cause a certain type of irregular heartbeat. Your doctor will talk to you about the risks and benefits of taking ELIGARD. The most common injection site adverse events are temporary burning and stinging, pain, bruising, and redness. The most common systemic adverse events include mild to severe hot flashes/sweats, fatigue, weakness, muscle pain, dizziness, clamminess, testicular shrinkage, and enlarged breasts. Other adverse reactions have been reported with drugs in ELIGARD's class. These include reduced bone density and rare but serious problems involving the pituitary gland.
Please see full Prescribing Information for additional important safety information.
SOURCE TOLMAR Pharmaceuticals, Inc.