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FDA reviewing Merck’s doravirine for HIV

January 8, 2018 10:45 PM UTC

FDA accepted for review two NDAs from Merck & Co. Inc. (NYSE:MRK) for doravirine (MK-1439) to treat HIV infection. One application covers a once-daily tablet of doravirine for use in combination with antiretrovirals, and the other covers a once-daily, fixed-dose combination tablet of doravirine with lamivudine and tenofovir. The PDUFA date for both applications is Oct. 23...

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