June 20, 2012
On June 18, 2012, FDA granted approval for a generic formulation of abacavir tablets, 300 mg, manufactured by Mylan Pharmaceuticals, indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
FDA has determined that the generic formulation is bioequivalent and, therefore, therapeutically equivalent to the reference listed drug, ZiagenTablets, a product of VIIV Healthcare Company.
Approval of this generic formulation means that it may be marketed in the United States.
A complete list of approved generic formulations of antiretroviral drugs used in the treatment of HIV infection is available on the FDA web site.
No comments have been made.