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U.S FDA issues complete response letter to ViiV Healthcare for the use of investigational cabotegravir and rilpivirine long-acting regimen for the treatment of HIV

Dec 21, 2019: ViiV Healthcare received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its application for cabotegravir and rilpivirine long-acting regimen for treatment of HIV-1 infection in virologically suppressed adults.

Cabotegravir is an integrase strand transfer inhibitor that is developed by ViiV Healthcare and rilpivirine – non-nucleoside reverse transcriptase inhibitor developed by Janssen Sciences Ireland UC. T

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he cabotegravir and rilpivirine are long-acting regimen and is an investigational product and not approved anywhere in the world.
https://www.gsk.com/en-gb/media/press-releases/viiv-healthcare-receives-complete-response-letter-from-us-fda-for-use-of-investigational-cabotegravir-and-rilpivirine-long-acting-regimen-in-the-treatment-of-hiv/

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