Indian drugmaker Wockhardt gets FDA approval for Parkinson’s drug Comtan

Indian drugmaker Wockhardt gets FDA approval for Parkinson’s drug ComtanMumbai-based pharma & healthcare company Wockhardt has gained the U. S. Food & Drugs Administration's permission to market a generic version of entacapone - a treatment for Parkinson's disease.

Entacapone is the generic name for the brand Comtan, which is owned by Orion Corporation of Finland and marketed in the U. S. by Novartis.

The Indian drugmaker will launch an authorized generic version of the tablet on September 30 this year.

Dr. Habil Khorakiwala, founder chairman and group chief executive officer of Wockhardt, said, "Pursuant to a settlement of the litigation between Wockhardt and Orion Corp., Wockhardt will launch an authorized generic version from Sept 30, 2012, with 180-days of exclusivity."

Khorakiwala claimed that Wockhardt was the first to file with paragraph-IV certification on the product.

Khorakiwala also said the U. S. continued to be one of biggest growing markets for Wockhardt, and the company was not witnessing any slowdown in demand.

According IMS Health's estimates, the total market for this tablet will jump to around 98 million this year.

Last week, Wockhardt had gained approval to market clopidogrel bisulfate tablets - a treatment for reducing heart attack risk - in the U. S. market.