Matrix Laboratories has been granted tentative approval for its ANDA for Valacyclovir Hydrochloride Tablets in the strength of 500mg and 1gm. It is the generic of Valtrex by GlaxoSmithKline. Valacyclovir Hydrochloride is used in the treatment of herpes virus infection and the product generated annual sales of US$ 1.30 billion in CY-2006. This approval represents third ANDA approval for Matrix Laboratories in a period of one month. Earlier, the Company was granted tentative approvals for Tenofovir Disoproxil Fumarate Tablets and Lamivudine and Zidovudine Tablets.

Earlier, in July-2007, Ranbaxy Laboratories reached an agreement with GlaxoSmithKline (GSK) to stipulate a dismissal of their US litigation with regard to Valacyclovir Hydrochloride Tablets. Under the agreement, the Company will enter the US market in late-2009 whereby the Company will enjoy a 180-days exclusivity period. Apart from Matrix Laboratories, three other Companies have received tentative approval for the product. These are; Sandoz, Teva Pharmaceuticals and Mylan Pharmaceuticals.

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