Mylan announced that the Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Nevirapine Extended-Release Tablets, the generic version of Boehringer Ingelheim’s Viramune XR.
Viramune XR is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the combination antiretroviral treatment of HIV-1 infection in patients aged 6 and older. Nevirapine binds directly to reverse transcriptase and blocks the RNA-dependent and DNA-dependent DNA polymerase activities by causing a disruption of the enzyme’s catalytic site. The activity of nevirapine does not compete with template or nucleoside triphosphates.
Nevirapine Extended-Release Tablets are available in a 400mg strength. Mylan has begun shipping the product.
For more information call (800) RX-MYLAN or visit Mylan.com.