Trade Resources Company News Wockhardt Gained Tentative FDA Approval for Marketing Ziprasidone

Wockhardt Gained Tentative FDA Approval for Marketing Ziprasidone

Wockhardt, a high-technology intensive pharmaceutical and biotechnology company, has gained tentative FDA approval for marketing Ziprasidone, a generic anti-psychotic drug Geodon.

The FDA approved generic version of 20mg, 40mg, 60mg and 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 2 September 2012.

Wockhardt founder chairman and group CEO 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."

The Ziprasidone HCl API will be manufactured at Wockhardt's facility at Ankleshwar, India and the capsules of Ziprasidone at its facility in Aurangabad, India.

 

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/wockhardt-wins-tentative-fda-approval-for-generic-geodon-230812
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Wockhardt Wins Tentative FDA Approval for Generic Geodon