India-based drug maker Wockhardt has received tentative approval to market its generic version of Geodon (ziprasidone), an anti-psychotic drug sold in the US by Pfizer.
The US Food and Drug Administration will allow the biotechnology company to sell 20mg, 40mg, 60mg and 80mg capsules containing Ziprasidone hydrochloride, which is used to treat bipolar disorders and schizophrenia.
Wockhardt will manufacture Ziprasidone HCl at its facility in Ankleshwar and develop the capsules in Aurangabad, India.
The company said it will launch the product on September 2, 2012.
This is the third FDA approval for Wockhardt this week. On August 20, the agency said it will allow the company to sell a generic version of Comtan (Entacapone), a Parkinson’s disease treatment owned by Orion Corporation and marketed in the US by Novartis.
A day later, the drug maker received final approval to market extended-release tablets containing Felodipine, which is used to treat hypertension.
Felodipine is the generic name for the Plendil, sold in the US by AstraZeneca.
Wockhardt founder, chairman and group CEO Dr Habil Khorakiwala said; "Wockhardt’s R&D has ensured a steady stream of new products, which has translated into a varied product offering in the US markets."
"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."