NEW DELHI, Aug 6: Drug firm Indoco Remedies on Thursday said it has received approval from the US health regulator for 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 US market size of Olanzapine tablets is USD 65 million.
Indoco Remedies Managing Director Aditi Kare Panandikar said this approval from the US health regulator will further supplement the solid dosage business for Indoco in the US.
Olanzapine is indicated for the treatment of schizophrenia and bipolar disorder. The drug may also be used in combination with other medication to treat depression and certain mental conditions.
(PTI)
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