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news.Mumbai-based pharmaceutical company Lupin has received tentative approval from the FDA for its abbreviated new drug application for ziprasidone hydrochloride capsules, the generic version of Pfizer's antipsychotic Geodon Capsules.
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Ziprasidone, an antipsychotic drug, is indicated for the treatment of schizophrenia and bipolar disorder. The FDA approval regards the ziprasidone hydrochloride capsules in 20mg, 40mg, 60mg and 80mg doses.
Lupin said the fact that it filed the abbreviated new drug application on the earliest possible date ensures that there will be limited competition when the product becomes generic.
Vinita Gupta, president and managing director of Lupin, commented: “We are pleased to receive this tentative approval for ziprasidone hydrochloride tablets. This product represents our second approval in the CNS segment and will be launched following final approval from the FDA.”
With this approval, Lupin now has 22 abbreviated new drug applications approved by the FDA.