Company Watch

Wockhardt gets US FDA approval for antibacterial Levofloxacin

Our News Bureau - Mumbai

Wockhardt has received tentative approval from the US FDA for marketing 250mg, 500mg and 750mg tablets of Levofloxacin, which is used for treatment in a broad spectrum of bacterial infections. Levofloxacin is the generic name for the brand Levaquin, marketed in the US by Ortho Mcneil (Johnson & Johnson).

The company will launch the product immediately upon expiration of the patent on June 20, 2011. Levofloxacin is a very widely used antibacterial drug and belongs to the fluoroquinolone group. According to IMS, the total market for Levofloxacin tablets in the US is about $1.6 billion.

"Ability to launch products on the date of patent expiration is the most critical element of success in the highly competitive US generics market," said Wockhardt Chairman Habil Khorakiwala. "Receiving the tentative approval will enable Wockhardt to plan a successful launch of Levofloxacin in the US. We have had a good start to the year 2010, with two tentative approvals in as many weeks," he further added.

In the US generic pharma market, Wockhardt has been consistently growing market shares for all its products. In many instances, Wockhardt, by virtue of being amongst the first to market, will gain advantages of being an early entrant.

The Levofloxacin tablets will be manufactured at the US FDA certified formulation plant at Waluj, Aurangabad. The tablets were developed in-house.