Sun Pharma gets USFDA nod for generic schizophrenia tablets

NEW DELHI: Sun Pharmaceutical Industries said it has received approval from the US health regulator for its generic Zyprexa Zydis tablets, used in treating mental disorder, in the American market.

The company said US Food and Drug Administration (USFDA) has granted approval for its abbreviated new drug application (ANDA) for generic version of Zyprexa Zydis, Olanzapine ODT, in strengths of 5 mg, 10 mg, 15 mg and 20 mg, Sun Pharma said in a statement.

"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," it added.

Olanzapine Orally Disintegrating tablets have annual sale of around USD 360 million in the US and are indicated for the treatment of schizophrenia, bipolar I disorder (manic or mixed episodes), the company said.

Shares of Sun Pharma closed at Rs 549.95 on the BSE, up 0.78 per cent from previous close.