Lupin Ltd has received tentative approval from the US FDA for it's Abbreviated New Drug Application (ANDA) for ziprasidone capsules 20 mg, 40 mg and 60 mg.
Ziprasidone, an antipsychotic drug, is indicated for the treatment of schizophrenia and bipolar disorder. The company flied the ANDA on the earliest possible NCE date, this ensures that there will be limited competition when the product goes generic.
The company's ziprasidone capsules are the AB-rated generic equivalent of Pfizer's Geodon capsules. Annual product sales in the US of the capsules were approximately $760 million for the twelve months ended December 2006, based on IMS data.
"The approval of our ziprasidone ANDA is our second approval in the CNS segment after our sertraline ANDA. In particular, this approval reinforces Lupin's ability on submitting high quality dossiers at the right time and gaining approval well in time," said Dr Kamal Sharma, managing director of the company.
With this approval, the company now has 22 ANDAs approved by the US FDA.