Wockhardt Ltd has announced that the Company 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, on day one the Company will launch Terbinafine, the generic version of brand Lamisil sold by Novartis.
"Our Wockhardt USA Inc. team is ready to embark on the 'Day-one' launch of Terbinafine," said the Company's Chairman Habil Khorakiwala. "The US market for Terbinafine tablets is about $ 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. The Company currently markets 20 products in the US.
"We now also have on the management board of Wockhardt USA Inc., President, Kurt Orlofski, who will spearhead the US Generics Business. We are confident that Wockhardt's generic business will scale greater heights and establish an important position in the generic industry," said Khorakiwala.