Prezista, known generically as darunavir, initially received approval for use in the United States on June 23, 2006.
Key Approval Dates for Prezista
Prezista is an antiretroviral medication primarily used in the treatment of Human Immunodeficiency Virus (HIV) infection. Its regulatory journey includes significant milestones reflecting its initial availability and subsequent expanded applications.
Initial FDA Approval
The initial U.S. Food and Drug Administration (FDA) approval for Prezista was granted on June 23, 2006. This marked its first official clearance for the treatment of HIV, making it available to patients requiring new therapeutic options.
Subsequent Approval and Expanded Indications
Following its initial market introduction, Prezista received further FDA approval on October 22, 2008. This subsequent approval specifically broadened its use, authorizing Prezista as a once-daily regimen. This particular approval was for its inclusion in combination therapy for adults with HIV-1 who had not previously received treatment, often referred to as treatment-naive patients. This expansion significantly enhanced its utility and broadened the patient population that could benefit from the medication.
To summarize the key approval milestones for Prezista:
| Date | Approval Description |
|---|---|
| June 23, 2006 | Initial U.S. FDA approval for Prezista for the treatment of Human Immunodeficiency Virus (HIV). |
| October 22, 2008 | U.S. FDA approval for Prezista as a once-daily regimen in combination therapy for treatment-naive adults with HIV-1. |
For more detailed information on Prezista's approval history and development, resources such as Drugs.com's Prezista history page provide comprehensive timelines.
