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  1. Human Immunodeficiency Virus (HIV)

What's New at CDER in HIV/AIDS

Get updates on safety and regulatory issues related to HIV/AIDS medical products such as:

  • product approvals
  • significant warnings
  • safety warnings
  • notices of upcoming public meetings
  • notices about proposed regulatory guidances

 

 
 
Date Subject
3/11/2021 The Food and Drug Administration approved revisions to the TRIUMEQ (abacavir/dolutegravir/lamivudine) and DOVATO (dolutegravir/lamivudine) labels
1/26/2021 FDA Approves Cabenuva and Vocabria for the Treatment of HIV-1 Infection
8/7/2020 FDA approved changes to the DOVATO (dolutegravir/lamivudine) product labeling to include a new indication and provide longer term safety and efficacy data
8/4/2020 FDA approved the product labeling for PREZCOBIX and EVOTAZ for use in pediatric patients
1/29/2020 PEPFAR: FDA launches mobile-friendly database with information on life-saving HIV drugs
10/30/2019 Label updates to efavirenz containing products
10/4/2019 DESCOVY for PrEP: Post-marketing commitment (PMC)

 

Access older postings to the FDA/HIV e-mail list*

*FDA recently made updates to part of their email based communication. You can still view the updates by going to Internet Archive Wayback Machine for FDA.gov. The For Patients section of FDA.GOV was backed up last on July 29, 2017. This non-profit Internet Archive has archived some (but not all) of FDA.gov pages and files since 1996.

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