FDA News

Indevus Announces FDA Approval Of SUPPRELIN-LA

(May 04, 2007)-- Indevus Pharmaceuticals announced that SUPPRELIN-LA (histrelin acetate subcutaneous implant) 50mg has been approved by the U.S. Food and Drug Administration (FDA). SUPPRELIN-LA is indicated for the treatment of central precocious puberty (CPP), the premature onset of puberty in children.

SUPPRELIN-LA is a once-yearly implant which utilizes the Company's patented hydron implant technology. The implant is inserted subcutaneously in the inner aspect of the upper arm and is specifically designed to provide a continuous release of approximately 65mcg/day over 12 months of the gonadotropin releasing hormone (GnRH) analog histrelin.

"CPP is an important and increasingly recognized condition that can have profound physical as well psychological impact on children and their families. The approval of SUPPRELIN-LA is a significant advancement in the treatment of CPP, providing a rapid and sustained suppression of hormone levels for a full year," stated James E. Shipley, M.D., senior vice president, clinical development and medical affairs of Indevus.

"SUPPRELIN-LA offers an attractive treatment option as the only product with a once-yearly dosing interval. Other therapies require injections every three to four weeks. SUPPRELIN-LA provides patients and their families a rapid and sustained treatment option that significantly reduces the inconvenience of frequent dosing and may improve long-term compliance."

"The approval of SUPPRELIN-LA is an important first step in recognizing the significant value in the recently acquired Valera pipeline and another on- time milestone achievement. We continue to execute on our plan to build a leading urology and endocrinology-focused specialty pharmaceutical company," continued Dr. Cooper. "Our hydron implant technology will now be utilized in two FDA approved products, SUPPRELIN-LA and VANTAS, and we are hopeful that it will be a catalyst for additional products based on this unique, patented technology."

Central precocious puberty is the premature development of body characteristics that normally occur during puberty. In females, this is usually defined as earlier than 8 years of age, and in males, as earlier than 9 years of age. Children with CPP also show significantly advanced bone age that can result in diminished adult height attainment as well as an increased likelihood of psycho-social problems.

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