New Delhi: Pharmaceutical firm Wockhardt on Wednesday said it has received tentative approval from US health regulator for its generic version of anti-psychotic drug Geodon.
The tentative marketing approval by the US Food and Drug and Administration of ziprasidone hydrochloride is for multiple strengths of 20mg, 40mg, 60mg and 80mg, the company said in a statement.
Ziprasidone capsule is the generic name for the brand Geodon, marketed in the US by Pfizer and is used in the treatment of bipolar disorders and schizophrenia.
"Wockhardt will launch the product on September 2, 2012," the company added.
Quoting IMS Health, the company said the total market for this product in the US is about USD 1.3 billion.
Commenting on the approval, Wockhardt Founder Chairman & Group CEO Habil Khorakiwala said: "This is the fifth USFDA approval for Wockhardt in the past eight days. Wockhardt's R&D has ensured a steady stream of new products, which has translated into a varied product offering in the US markets".
Wockhardt will be manufacturing the ziprasidone hydrochloride active pharmaceutical ingredient in its facility at Ankleshwar and the capsules of Ziprasidone at its facility in Aurangabad.
Shares of Wockhardt were trading at Rs 1,264.15 a piece in late afternoon trade on the BSE, up 0.06 percent from their previous close.
First Published: Wednesday, August 22, 2012, 16:16