Indoco Remedies’ Olanzapine tablets gets USFDA approval


A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. (Photo by Sarah Silbiger/Getty Images)
A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. (Photo by Sarah Silbiger/Getty Images)

DRUG FIRM Indoco Remedies has said that it has received approval from the US health regulator for Olanzapine tablets, used 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 $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.

According to the company, the drug may also be used in combination with other medication to treat depression and certain mental conditions.

Indoco Remedies is a fully integrated, research-oriented pharma company engaged in the manufacturing and marketing of Formulations (Finished Dosage Forms) and Active Pharmaceutical Ingredients (APIs).

Based in Mumbai, it has seven decades of presence in the Indian Pharma market and a strong foothold in the international market across 55 countries.

The $145 million company employs around 6000 personnel, including over 300 skilled scientists.