Wockhardt amongst first to receive US FDA approval for Zonisamide Capsules
26 December 2005
Wockhardt Ltd has become amongst first to receive approval from the US FDA for marketing Zonisamide capsules in the US market. Zonisamide is the generic version of Dainippon''s Zonegran capsules.
As per IMS data, the current market of Zonisamide in the US is $ 74 million. The overall anti-epileptic market is of $8 billion.
''Wockhardt will be amongst the first company to launch generic Zonisamide in the US," says Habil Khorakiwala, chairman, Wockhard. "We have received this ANDA approval in less than nine months from the filing, which is a reflection of Wockhardt''s quality of research and the capability of our regulatory affairs. We are end-to-end integrated with this product right from manufacturing of both API and capsule formulation to marketing the product in the US," he added. "Zonasimide is the first compound of its class to be developed as an anti-epileptic agent. It has broad spectrum of anti-epileptic activity, and is particularly beneficial in refractory partial seizures and to a more variable extent in generalised and compound / combination seizures", said Khorakiwala,
Wockhardt is a technology-oriented pharmaceutical and biotechnology and one of its new drug discoveries has entered phase II human clinical trials. The US and the European Union contribute to half the company''s turnover.