PARSIPPANY, N.J. and MUMBAI, India, today announced that - Pharmaceutical and biotechnology major Wockhardt has received tentative US FDA approval for marketing a generic version of 20mg, 40mg, 60mg & 80mg capsules containing Ziprasidone hydrochloride, which is used in the treatment of bipolar disorders and schizophrenia. Ziprasidone capsule is the generic name for the brand Geodon, marketed in the US by Pfizer. Wockhardt will launch the product on Sept 02, 2012.
According to IMS Health, the total market for this product in the US is about $1.3 billion.
"This is the fifth US FDA approval for Wockhardt in the past 8 days," said Dr. Habil Khorakiwala, Wockhardt Founder Chairman & Group CEO. "Wockhardt's R&D has ensured a steady stream of new products, which has translated into a varied product offering in the US markets," he further added.
In the US generic pharmaceutical market, Wockhardt has been consistently growing market shares for all its products. In many instances, Wockhardt, by virtue of being amongst the few players to market technically challenging products has reaped the advantage of being an early entrant.
Wockhardt will be manufacturing the Ziprasidone HCl API in its facility at Ankleshwar, India and the capsules of Ziprasidone at its facility in Aurangabad, India. The technology for the API and the capsules were developed in-house.
PR Newswire