Wockhardt gets US FDA tentative nod for Levofloxacin tablets

NEW DELHI: Pharma major Wockhardt on Wednesday said it has received tentative approval from the US drug regulator to market Levofloxacin tablets, used for treatment in a broad spectrum of bacterial infections.

The United States Food & Drug Administration (USFDA) has given its approval for marketing Levofloxacin tablets in the strengths of 250mg, 500mg and 750mg, Wockhardt Ltd said in a statement.

Levofloxacin is the generic name for the brand Levaquin, marketed in the US by Ortho Mcneil (Johnson & Johnson).

The Mumbai-based pharmaceutical firm will launch the product immediately upon expiration of the patent on June 20, 2011, it said.

Levofloxacin is a widely used antibacterial drug and belongs to the fluoroquinolone group. According to the IMS, the total market for Levofloxacin tablets in the US is about $1.6 billion.

"Receiving the tentative approval will enable Wockhardt to plan a successful launch of Levofloxacin in the US. We have had a good start in the year 2010, with two tentative approvals in as many weeks," Wockhardt chairman Habil Khorakiwala said.

In the US generic pharmaceutical market, Wockhardt has been consistently growing market shares for all its products.

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