Mumbai: Domestic pharma company Lupin Ltd on 21 May 2007 said it has received tentative approval from the United States Food and Drug Administration for its Ziprasidone, an anti-psychotic drug in multiple strengths.
The company has received tentative USFDA approval for its Abbreviated New Drug Application (ANDA) for Ziprasidone capsules of 20 mg, 40 mg and 60 mg.
“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”, Lupin Managing Director Kamal Sharma said.
Ziprasidone is an anti-psychotic drug and is used for schizophrenia and bipolar disorder.
The company flied ANDA on the earliest possible New Chemical Entity (NCE) date, which would ensure that there would be limited competition when the product goes generic, Lupin said in a communique to the Bombay Stock Exchange.
Lupin’s Ziprasidone capsules are the AB-rated generic, which are equivalent of Pfizer’s Geodon capsules.
Last year, these capsules were worth $760 million in the US, the company said.
The shares of the company were trading at Rs723, up 1.27% on BSE in afternoon trade.