Natco Pharma Submit New Application with US FDA for Generic Cancer Drug


On Monday, February 13, 2023, Natco Pharma announced that it had submitted a new application to the US health regulator for marketing authorization of the generic version of Olaparib tablets, which are used to treat some types of ovarian, breast, pancreatic, and prostate cancer.

The generic version of AstraZeneca’s Olaparib tablets in strengths of 100mg and 150mg has been submitted by the company to the US Food and Drug Administration (FDA) in an ANDA (Abbreviated New Drug Application), along with a paragraph IV certification.

AstraZeneca has been selling Olaparib tablets under the brand name called ‘Lynparza’ in the United States of America (USA). A lawsuit brought by AstraZeneca and Kudos Pharmaceuticals in the United States district court for the state of New Jersey named Natco Pharma as a defendant.

According to Natco Pharma, based on its filing date, the company and its co-development and marketing partner Alembic Pharmaceuticals believe that the ANDA may be eligible for 180 days of marketing during the product launch.

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Lynparza’s US sales for the year ended December 2022, according to AstraZeneca, totaled USD 1,226 million. On the BSE (Bombay Stock Exchange), Natco Pharma shares were trading at Rs 537.50 each, up 2.2 percent.