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Viramune? (nevirapine) prolonged-release once-daily formulation for the treatment of HIV-1 infection receives approval in the EU

Fri, 09/23/2011 - 9:25am
Manufacturing.net

Viramune® (nevirapine) prolonged-release once-daily formulation for the treatment of HIV-1 infection receives approval in the EU

Ingelheim, Germany, September 21, 2011 – Boehringer Ingelheim announced today that once-daily Viramune® (nevirapine) prolonged-release has received approval for use in the EU. 1 The new, prolonged-release tablet is indicated in combination with other antiretroviral medications for the treatment of HIV-1 infection.

EU approval for the use of one 400 mg tablet once daily for adults and adolescents - and for 50 mg and 100 mg strengths for once-daily treatment of children - is based on results from clinical trials confirming the significant therapeutic benefits of nevirapine when administered in a convenient once-a-day formulation. 2,3

The Viramune® XR™ single 400 mg tablet once daily was approved in the USA by the Food and Drug Administration (FDA) earlier this year.

In clinical trials, the antiviral efficacy of Viramune® prolonged-release tablets was shown to be non-inferior to the older, twice-daily immediate-release (IR) 200mg tablet, 2,3 with a safety and tolerability profile comparable to nevirapine IR.

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