FDA Approves Nevirapine XR

On 25 March 2011, the FDA approved an extended release formulation of nevirapine XR (Viramune-XR) 400 mg extended release tablet.

The approval is based on one principal clinical trial (1100.1486) that demonstrated prolonged suppression of HIV-1 RNA through 48-weeks, and a supportive trial (1100.1526).

Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled studies, nevirapine should not be initiated in adult females with CD4+ cell counts greater than 250 cells/mm³ or in adult males with CD4+ cell counts greater than 400 cells/mm³ unless the benefit outweighs the risk

The 14-day lead-in period with immediate-release nevirapine 200 mg daily dosing must be strictly followed; it has been demonstrated to reduce the frequency of rash.

If rash persists beyond the 14-day lead-in period with immediate-release nevirapine, do not begin dosing with nevirapine XR. The lead-in dosing with 200 mg once-daily should not be continued beyond 28 days, at which point an alternative regimen should be sought.

Comment

Filing in Europe for nevirapine XR has already taken place with a decision from the EMA expected in the third quarter of 2011.

Source: FDA list serve.

The complete product label will be posted at:
www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Links to external websites are current at time of posting but not maintained.