Ranbaxy gains final approval for generic valacyclovir

Ranbaxy Pharmaceuticals, the wholly-owned US subsidiary of India's Ranbaxy Laboratories, has received final approval from the US Food and Drug Administration to market valacyclovir HCl tablets, 500mg (base) and 1g (base). The FDA's Division of Bioequivalence has determined the Ranbaxy formulation to be bioequivalent and, therefore, therapeutically equivalent to GlaxoSmithKline's Valtrex Caplets, 500mg (base) and 1g (base), respectively. Valacyclovir had sales totaling $1.26 billion in the 12 months to September 2006, according to IMS Health data quoted by Ranbaxy.

Valacyclovir is indicated for the treatment of herpes zoster (shingles), therapy or suppression of genital herpes in immunocompetent individuals and for the suppression of recurrent genital herpes in HIV-infected individuals, as well as being indicated for of cold sores (herpes labialis).