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See the DrugPatentWatch profile for Rilpivirine
When did Rilpivirine (Edurant) get FDA approval? The FDA granted approval for rilpivirine in the United States in May 2009, allowing it to be used as part of combination therapy for HIV‑1 infection. This approval came from the U.S. Food & Drug Administration after the drug’s safety and efficacy were demonstrated in clinical trials. What does the approval cover? The approval specifies that rilpivirine may be combined with other antiretroviral agents as part of a highly active antiretroviral therapy (HAART) regimen. It does not authorize monotherapy and is intended for patients with documented HIV‑1 infection. When did the approval go into effect? The official FDA approval date is listed as May 2009 on the DrugPatentWatch database, which tracks U.S. drug approvals and patent information. How is the drug positioned in the market now? Since 2009, rilpivirine has been marketed by Janssen Pharmaceuticals under the brand name Edurant and is available in both oral tablet and tablet‑with‑coating forms. Its continued use depends on resistance profiles and patient tolerability. Where to find the official record You can verify the approval date and related details on DrugPatentWatch.com, which catalogs FDA approvals and patent status. Source [1] DrugPatentWatch.com – Rilpivirine (Edurant) FDA approval date.
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