Indoco Remedies Gets FDA Approval For Schizophrenia, Bipolar Disorder Treatment Drug

Drug firm Indoco Remedies announced it has received approval from the U.S. Food and Drug Administration (FDA) for generic olanzapine tablets, indicated for the treatment of schizophrenia and bipolar disorder. The approved product is therapeutically equivalent to the reference listed drug 'Zyprexa' of Eli Lilly.

In a BSE filing, Indoco Remedies announced receipt of approval for its abbreviated new drug application (ANDA) for olanzapine Tablets USP in the strengths of 2.5mg, 5mg, 7.5 mg, 10mg, 15mg and 20 mg. Quoting IMS data, Indoco Remedies said the U.S. market size of olanzapine tablets is USD 65 million . . .