Sun Pharma gets USFDA approval for generic Zyprexa Zydis tablets

29 Feb 2012 Evaluate

Sun Pharmaceutical Industries has received an approval from US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for generic version of Zyprexa Zydis, Olanzapine ODT, 5 mg, 10 mg, 15 mg and 20 mg.

These generic Olanzapine orally disintegrating tablets, 5 mg, 10 mg, 15 mg and 20 mg are therapeutic equivalents of Eli Lilly’s Zyprexa Zydis tablets. Olanzapine orally disintegrating tablets have annual sale of approximately $360 million in the US.

Olanzapine OD tablets are indicated for the treatment of schizophrenia, bipolar I disorder (manic or mixed episodes).

Sun Pharmaceutical Industries manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world.

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