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Taro receives US FDA nod for lamotrigine tablets
Hawthorne, New York | Friday, January 30, 2009, 08:00 Hrs  [IST]

Taro Pharmaceutical Industries Ltd. has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for lamotrigine tablets 25 mg, 100 mg, 150 mg, and 200 mg. Taro had received tentative approval for this ANDA in March 2008.

Lamotrigine is a prescription product used for the treatment of seizures and is bioequivalent to GlaxoSmithKline's Lamictal tablets. According to industry sources, lamotrigine tablets had annual US sales of more than $2 billion.

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.

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