Wockhardt will launch the product immediately upon expiration of the patent on June 20, 2011. Levofloxacin is a widely used antibacterial drug and belongs to the fluoroquinolone group, said the company.
Habil Khorakiwala, chairman of Wockhardt, said: “Ability to launch products on the date of patent expiration is the most critical element of success in the highly competitive US generics market. 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.”
The Levofloxacin tablets will be manufactured at the FDA certified formulation plant at Waluj, Aurangabad, India. The tablets were developed in-house.