Lupin gets tentative US FDA approval for Ziprasidone

New Delhi, May 21 (UNI) Lupin Ltd, country's largest producer of anti-tuberculosis drugs, has received tentative approval from the US FDA for its 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 approval of Ziprasidone ANDA is our second approval in the CNS segment after 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.

With this approval, Lupin now has 22 ANDAs approved by the US FDA, a statement said today.

The company's Ziprasidone Capsules are the AB-rated generic equivalent of Pfizer's Geodon Capsules.

UNI