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Drug news

Tesaro files rolling submission at FDA for niraparib to treat ovarian cancer.

Read time: 1 mins

Last updated:30th Nov 2017

Published:14th Sep 2016

Source: Pharmawand

Tesaro announced that the FDA has granted Fast Track designation to niraparib for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. Tesaro has initiated a rolling submission of a New Drug Application (NDA) for niraparib to the FDA, and intends to complete this submission during the fourth quarter 2016. The Marketing Authorization Application (MAA) for niraparib is planned for submission to the European Medicines Agency (EMA) in the fourth quarter.

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