Wockhardt receives US FDA approval for antibacterial Levofloxacin

Pharmaceutical and biotechnology major Wockhardt has received tentative approval from the United States Food and Drug Administration (US FDA) for marketing 250mg, 500mg and 750mg tablets of its anti-bacterial drug Levofloxacin.

Levofloxacin, which is used for treatment in a broad spectrum of bacterial infections, is the generic name for the brand Levaquin. The drug is marketed in the United States by Ortho Mcneil (Johnson & Johnson).

Wockhardt plans to launch the product immediately upon expiration of the patent on 20 June 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.

Wockhardt said, it has been consistently growing market shares for all its products in the US generic pharmaceutical market. Wockhardt, by virtue of being amongst the first to market, will gain advantages of being an early entrant, the release said.

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