Bensalem, PA – November 30, 2012 – Sigmapharm Laboratories, LLC, announced today that it has received approval from the U.S. Food and Drug Administration (“FDA”) for its Abbreviated New Drug Application for Liothyronine Sodium Tablets, USP 5 mcg, 25 mcg and 50 mcg, the generic equivalent of King Pharmaceuticals, Inc.’s reference listed drug Cytomel® Tablets, USP 5 mcg, 25 mcg and 50 mcg. The company will be launching its Liothyronine product line immediately.
This product was developed using one of Sigmapharm’s new proprietary technology platforms, and possesses exceptional drug uniformity and stability properties. Currently, all strengths of Sigmapharm’s Liothyronine Sodium Tablets will be marketed with 2 years of shelf-life and, upon conclusion of further stability studies, the company plans to seek FDA approval to extend the shelf-life of its Liothyronine product line for at least up to 3 years.
“I am very pleased that Sigmapharm is now bringing to the health care community this exceptionally stable and uniform Liothyronine product line, which is actually the first product to be launched by Sigmapharm’s own Sales and Marketing team under Sigmapharm’s label,” said Dr. Spiro Spireas, Chairman and Chief Executive Officer of Sigmapharm Laboratories. Dr. Spireas also emphasized that “historically, this type of hormonal products have been inundated with various stability issues causing product recalls that may adversely affect their supply chain. We are very proud that all three strengths of our company’s Liothyronine tablets decisively overcome these problems because they are made using cutting edge formulation and manufacturing breakthroughs which ensure products possessing optimal and unique stability properties and drug uniformity characteristics.”
For sales and marketing information related to the Liothyronine product line, please contact Sales & Marketing, at 215-352-6647.
