FDA Gives Nod to Lmotrigine in Tablets Form
FDA Gives Nod to Lmotrigine in Tablets Form

Lupin Ltd. shared that US Food and Drug Administration has given approval, for its US subsidiary Lupin Pharmaceuticals’ lamotrigine in tablets form. These tablets are used in the treatment of bipolar-I disorder. The Company revealed that these tablets are a generic version of GlaxoSmithKline's branded drug Lamictal, and have annual sales of about $452 million in the US market.

Lamotrigine is an effective mood stabilizer, akin to many other anticonvulsant medications. It is the only FDA approved drug for this purpose since lithium, which was approved 30 years ago.

While the benchmark Sensex closed 0.6% up at 17,117 points, shares for Lupin ended 0.1% up at Rs. 1,849 on the Bombay Stock Exchange, on Friday. U. S subsidiary, Lupin Pharmaceuticals, Inc. has got the final approval the Company's Abbreviated New Drug Application, for its Lamotrigine tablets, 25 mg, 100 mg, 150 mg and 200 mg strengths.

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