Wockhardt gets US nod for Levofloxacin
New Delhi: Pharmaceutical major Wockhardt has received tentative approval from the US Food and Drug Administration (FDA) for marketing the 250 mg, 500 mg and 750 mg tablets of Levofloxacin, used for treatment of bacterial infections.
Levofloxacin is the generic name for the brand Levaquin, marketed in the US by Ortho Mcneil (Johnson & Johnson). Wockhardt will launch the product immediately upon expiration of the patent on June 20, 2011, the company said in a statement.
Levofloxacin is a very widely used antibacterial drug and belongs to the fluoroquinolone group. 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 added.
The Levofloxacin tablets will be manufactured at the US FDA certified formulation plant at Waluj, Aurangabad, the company said.