Lupin Ltd has received tentative approval from the US FDA for it''s abbreviated new drug application (ANDA) for Ziprasidone capsules 20mg, 40mg and 60mg.

Ziprasidone, an antipsychotic drug, is indicated for the treatment of schizophrenia and bipolar disorder. As Lupin was the first to file its ANDA as a new chemical entity (NCE) it will face limited competition when the product goes generic.

Lupin''s Ziprasidone capsules are the AB-rated generic equivalent of Pfizer''s Geodon capsules, the annual sales of which in the US for the twelve months ended December 2006, were approximately $760 million (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, Lupin Ltd .

Lupin now has 22 ANDAs approved by the US FDA.