Once-daily nevirapine approved in Europe
On 21 September 2011 Boehringer Ingelheim announced that the once-daily formulation of extended release nevirapine (Viramune XR) had received approval for use in the EU
The new 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.
This formulation still requires a lead-in dose of 200 mg once-daily with the original twice-daily formulation of nevirapine, with a caution not to increase the dose if rash is present at day 14.
Nevirapine-XR was approved by the Food and Drug Administration (FDA) in the US in March 2011.
Source: Boehringer Ingelheim press release. Viramune® (nevirapine) prolonged-release once-daily formulation for the treatment of HIV-1 infection receives approval in the EU. (21 September 2011).