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Wockhardt gets US FDA nod to enter the $680 million Lamisil market |
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01 Jun 2007 |
Seventh ANDA approval in 3 months
MUMBAI, India | May 31, 2007 | Pharmaceutical and biotechnology major Wockhardt 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 Wockhardt 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 Wockhardt 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 Wockhardt’s US FDA certified formulation plant at Waluj, Maharashtra. Market shares of all Wockhardt USA products are exhibiting a good growth. Wockhardt 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.
Wockhardt Limited is a global pharmaceutical and biotechnology major with an innovative research and development programme. Wockhardt has global footprints and manufacturing organisations including UK, France, Germany, Ireland and USA. Wockhardt employs 5500 people worldwide belonging to 14 different nationalities.
SOURCE: Wockhardt Limited |
