FDA approves King's Levoxyl
King Pharmaceuticals has received US Food and Drug Administrationapproval for its New Drug Application for Levoxyl (levothyroxine sodium) in the treatment of hypothyroidism and suppression of the thyroid-stimulating hormone. This approval follows a request by the FDA that all manufacturers of levothyroxine should file new drug applications, due to stability problems, in 1997 (Marketletters passim).
King's chairman and chief executive, John Gregory, says that the company is "extremely pleased with the sales growth of Levoxyl this year," which rose 17% in the first quarter to $17.3 million, and is expected to exceed $20 million in the second quarter. The approval gives King an opportunity to increase its share of the US market for levothyroxine, currently dominated by Abbott Laboratories' Synthroid, as Abbott is still in the process of filing an NDA for its drug (Marketletter May 7), although it remains on the market in the interim.
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