Fera Pharmaceuticals and Oakwood Laboratories have announced that on June 29, 2016, the FDA approved their ANDA for 100 and 500 mcg Levothyroxine Sodium for Injection. The ANDA is owned jointly by Fera and Oakwood. Indicated for myxedema coma, the companies believe the product will enjoy 180-day generic drug exclusivity upon launch.
Frank DellaFera, president at Fera stated “The approval of this ANDA is an important milestone at Fera and also demonstrates FDA efficiency in handling a file granted expedited review.” Mark T. Smith, president at Oakwood, indicated “Obtaining first approval of this product is a tribute to the Oakwood product development group’s diligence and expertise.”
According to IMS Health, sales for the Reference Listed Drug, Fresenius Kabi’s Levothyroxine, were over $93,000,000 during the twelve months ending May 2016.
Warnings for Levothyroxine Sodium for Injection include risk of cardiac complications in elderly and in patients with cardiovascular disease and need for concomitant glucocorticoids and monitoring for other diseases in patients with endocrine disorders. Levothyroxine Sodium for Injection is not indicated for treatment of obesity. Excessive doses of levothyroxine can predispose to signs and symptoms compatible with hyperthyroidism. The signs and symptoms of thyrotoxicosis include, but are not limited to: exophthalmic goiter, weight loss, increased appetite, palpitations, nervousness, diarrhea, abdominal cramps, sweating, tachycardia, increased pulse and blood pressure, cardiac arrhythmias, angina pectoris, tremors, insomnia, heat intolerance, fever, and menstrual irregularities.