Lupin Gets US FDA Approval To Market Topiramate Pills

Leading drugmaker Lupin announced that it has received tentative Lupin Receives USFDA Nod For Topiramate Tabletsapproval from the US Food and Drug Administration (US FDA) for marketing multiple strengths of Topiramate tablets.

The company said that it has got approval to market dosages of 25 mg, 50 mg, 100 mg and 200 mg.

Lapin’s Topiramate pills are the AB rated generic equivalent of Ortho-McNeil’s Topmax tabs prescribed for treating seizures.

Topamax had sales of about $2.2 billion in the year ended March 2008.

Mr. Kamal Sharma, managing director said, ``Lupin is please to receive this approval that will enable the company to offer Topiramate tablests as an affordable generic alternative that will have a measurable impact on the US healthcare system.``

Lupin is one of the world’s largest drug makers that combat tuberculosis, bacterial infections, and cardiovascular disease.

At 2:09 p.m., the shares of the company gained 0.5% to trade at Rs 708 on the Bombay Stock Exchange (BSE).