FDA Approves Bioniche Pharma ANDA for Sotradecol Injection for the Treatment of Varicose Veins
-- product used to treat varicose veins -
BELLEVILLE, ON, November 22, 2004 – Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced that its Human Health Pharma Division has received approval for an Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for Sotradecol Injection (Sodium Tetradecyl Sulfate Injection) for the treatment of varicose veins.
“This ANDA approval is a significant addition to our product portfolio,” said Albert Beraldo, President & CEO of Bioniche Pharma Group Limited. “No other FDA-approved Sodium Tetradecyl Sulfate Injection is currently available in the U.S.” The ANDA was granted “expedited review” status because there is a nation-wide shortage of this medically necessary drug product. The Bioniche product (Sotradecol) will be available by mid-December in two strengths – 1% and 3% - packaged in 2 ml vials.
Sotradecol has been shown to be an effective treatment of small, uncomplicated varicose veins of the lower extremities. It is used in sclerotherapy (non-surgical vein removal). An estimated 1.7 million patients undergo sclerotherapy each year in the U.S.
“The approval of Sotradecol by the FDA represents an exciting new breakthrough in the management of venous disease,” said Dr. Neil S. Sadick, MD, FACP, FAACS, immediate Past President of the American College of Phlebology (New York). “The practicing phlebologist now has an approved standard option for treating his or her patients with both spider and varicose veins. This approval will have a major national impact, improving patient care in the U.S.”
“My practice has been limited to phlebology since 1985 with sclerotherapy as its centerpiece,” said Dr. Mark D. Forrestal, MD, FACPh, Treasurer of the American College of Phlebology (Chicago). “Sotradecol as a sclerosant has proven to be highly effective for small and large veins with a safe record. Combined with ambulation and compression, varicose veins have fibrosed as followed by duplex ultrasound studies.”
Graeme McRae, President & CEO of Bioniche Life Sciences Inc. added, “Our Pharma Division has been very successful in obtaining regulatory approval for a range of pharmaceuticals, such as Sotradecol. These strategic additions to our product portfolio help to ensure a continual revenue stream which supports further investment in research and development to bring our proprietary technologies to commercialization.”