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Required PMS case reports reduced for Genvoya and Descovy

By Lee, Hye-Kyung | translator Alice Kang

22.02.19 06:00:45

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In consideration of their reduced sales due to release of follow-on drugs

Unable to reach an agreement on ¡®including retrospective investigations as evidence cases for PMS report¡¯

The number of evidence cases reported for post-marketing surveillance of HIV treatments ¡®Genvoya tab (emtricitabine / tenofovir alafenamide/ cobicistat / elvitegravir)¡¯ and ¡®Descovy tab (emtricitabine / tenofovir alafenamide) that are subject to reevaluation will be adjusted.

Genvoya and Descovy, which received marketing authorization from the Ministry of Food and Drug Safety in September 2016 and February 2017, respectively, are up for reexamination by September 12th and have been conducting post-marketing surveillance for 6 years since their release.

The PMS cases that were required for the report are 3000 cases for Genvoya and 600 for Descovy, but the Central Pharmaceutical Affairs Cou

Lee, Hye-Kyung(hgrace7@dailypharm.com)
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