FLASCO / TOLMAR wins FDA approval for ELIGARD to treat Advanced Prostate Cancer

FLASCO
May 12, 2016
Drugs

TOLMAR Pharmaceuticals has secured 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”.

About TOLMAR

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.

Source: Company Press Release