Taro Pharmaceutical Industries Ltd. reported that it has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for lamotrigine tablets (chewable dispersible), 5 mg and 25 mg (lamotrigine chewable tablets).
Lamotrigine chewable tablets, marketed by GlaxoSmithKline as Lamictal CD tablets, are a prescription pharmaceutical product used in treating seizures. Taro previously filed a "Paragraph IV" certification challenging GlaxoSmithKline's patent protection on Lamictal. According to industry sources, lamotrigine chewable tablet products had annual US sales of approximately $70 million.
Taro Pharmaceutical Industries Ltd. is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.