Indoco gets USFDA approval for Olanzapine tablets

Indoco Remedies has received approval for its ANDA for Olanzapine tablets USP 2.5mg, 5mg, 7.5 mg, 10mg, 15mg and 20 mg. The products are therapeutically equivalent to the Reference Listed Drug ‘Zyprexa’ of Eli Lilly.

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.

The US market size of Olanzapine tablets is $65 million as per available IMS data.

Commenting on this development, Aditi Kare Panandikar, MD, Indoco Remedies said, “The receipt of approval from the US health regulator to market the generic version of Olanzapine tablets is very encouraging and will further supplement the solid dosage business for Indoco in the US.”