Wockhardt gets US FDA nod to market Terbinafine tablets

Mumbai, May 31 (UNI) Wockhardt has said it has received US FDA tentative approval to market Terbinafine tablets (Lamisil) in the United States.

Terbinafine is used to treat fungal infections such as onychomycosis (condition that affects the toenails or the fingernails).

With the US product patent for this drug expiring on June 29, 2007, the Company will launch Terbinafine, the generic version of brand Lamisil sold by Novartis.

Company chairman Habil Khorakiwala stated, ''Our Wockhardt USA Inc. team is ready to embark on the 'Day-one' launch of Terbinafine.

The US market for Terbinafine tablets is about USD 680 million.

Tapping this market, in addition to our speedily increasing product portfolio is a manifestation of our rapidly expanding capabilities in the US.'' The Terbinafine tablets are manufactured at the Company's US FDA certified formulation plant at Waluj, Maharashtra. Market shares of all Wockhardt USA products are exhibiting a good growth and the Company currently markets 20 products in the US.

UNI