The United States Food and Drug Administration, USFDA on Thursday gave approval to the drug firm Indoco Remedies. For Olanzapine tablets, indicated for the treatment of schizophrenia and bipolar disorder. The approval was received for its abbreviated new drug application (ANDA) for Olanzapine Tablets USP in the strengths of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg, announced Indoco Remedies in a BSE filing.
This product is therapeutically equivalent to the reference list drug ‘Zyprexa’ of Eli Lilly.
“The approval from the US health regulator will further supplement the solid dosage business for Indoco in the US”, said Aditi Kare Panandikar Managing Director of Indoco Remedies.
Quoting IMS data, Indoco Remedies said the US market size of Olanzapine tablets is USD 65 million.
Olanzapine belongs to a class of drugs called atypical antipsychotics. It is used to treat schizophrenia and certain types of bipolar disorders. It is also used in combination with an antidepressant to treat depression that can’t be controlled with other drugs.
Indoco Remedies focuses on APIs and formulations business in both domestic as well as international markets. Today, it has a well-built brand portfolio of 135 products in various therapeutic segments.
Shares of Indoco Remedies were trading 1.67 percent higher at Rs. 238.05 apiece on BSE.