May 24 2007
Lupin Pharmaceuticals has announced that on May 16, 2007 it received tentative approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Ziprasidone Hydrochloride Capsules 20mg, 40mg, 60mg and 80mg.
Ziprasidone, an antipsychotic drug, is indicated for the treatment of schizophrenia and bipolar disorder. Given that the company filed the ANDA on the earliest possible NCE date, this ensures that there will be limited competition when the product goes generic.
Lupin's Ziprasidone HCl Capsules are the AB-rated generic equivalent of Pfizer's Geodon(R) Capsules. Annual product sales in the U.S. of the capsules were approximately $760 million for the twelve months ended December 2006, based on IMS data.
Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc. 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 ANDAs approved by the US FDA.
Study focuses on COPD progression in younger populations