Lannett Company Inc announced the addition of Levothyroxine Sodium Tablets to its product line. The manufacturer of the product, Jerome Stevens Pharmaceuticals Inc (JSP), has granted Lannett the exclusive marketing and distribution rights effective immediately.
Levothyroxine Sodium Tablets are used to treat hypothyroidism and other thyroid disorders. In 2002, it was the 2nd most prescribed drug in the United States with over 13 million patients. With its distribution of this product, Lannett will enter into a market which is currently controlled by 3 branded Levothyroxine Sodium Tablet products -- Abbott Laboratories' Synthroid, Monarch Pharmaceutical's Levoxyl and Forest Laboratories' Levothroid.
The JSP product was the world's first New Drug Application (NDA) for a Levothyroxine Sodium Tablet formulation, approved by the Food and Drug Administration (FDA) in August 2000. Both Synthroid and Levoxyl were approved by the FDA after the JSP product was approved.
Forest Laboratories' Levothroid has not been approved by the FDA. According to NDCHealth, the combined 2002 retail sales for all Levothyroxine Sodium Tablet products was approximately $1.1 billion. Lannett expects to begin its distribution of the product immediately. A Company spokesperson stated "the product adds approximately 20 stock keeping units (SKUs) to our line, with 11 different dosage strengths."