Bioniche Life Sciences Inc, a Canadian biopharmaceutical company, announced that its Human Health Pharma Division has received approval for an Abbreviated New Drug Application (ANDA) from the US FDA for Sotradecol Injection (Sodium Tetradecyl Sulfate Injection) for the treatment of varicose veins.
Albert Beraldo, president & CEO of Bioniche Pharma Group Limited said, "No other FDA-approved Sodium Tetradecyl Sulfate Injection is currently available in the US." 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, the company said here.
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 US.
"The approval of Sotradecol by the FDA represents an exciting new breakthrough in the management of venous disease," Dr. Neil S. Sadick, immediate Past President of the American College of Phlebology (New York) said adding, "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 US."
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."