Natco Pharma Ltd has informed that the company's application for abbreviated new drug (ANDA) for ondansetron hydrochloride tablets in multiple strengths 4 mg and 8 mg has been approved by the US Food and Drug Administration.
As a consequence, the company can now sell its ondansetron tablets in the United States. It has already shipped out the first consignment of these tablets meant for distribution in the USA through its marketing partners.
Ondansetron hydrochloride is a popular anti-emetic, commonly used by cancer patients. The market for ondansetron generics, all over the US is expected to be in the region of around US $1.5 Billion.
For the company, this is the first drug to be approved by the US FDA and its ANDAs for other drugs are under various stages of approval. With these approvals coming through, the company expects to fortify its presence in the US markets. The company is in the process of establishing a retail chain in the US and hopes that the chain would serve a useful purpose in distributing and marketing its approved products.