FDA Hepatitis Update - Approval of Tyzeka for treatment of chronic hepatitis B (HBV

From: U.S. Food & Drug Administration (FDA)
Date: Thu, 30 Apr 2009 12:46:01 -0500 (CDT)
Subject: FDA Hepatitis Update - Approval of Tyzeka for treatment of chronic hepatitis B (HBV)

On April 28, 2009, FDA approved Tyzeka (telbivudine), an HBV nucleoside analogue reverse transcriptase inhibitor, in a new oral solution, 100 mg/5 mL solution supplied in 300 mL bottle, for the treatment of chronic hepatitis B in adult patients with evidence of viral replication and active liver inflammation (either evidence of persistent elevations in serum aminotransferases [ALT or AST] or histologically active disease) and chronic hepatitis B patients with renal impairment who may require a dose reduction. Tyzeka oral solution may also be considered for patients who have difficulty with swallowing tablets.

Tyzeka tablets, 600 mg film coated tablets for treatment of chronic hepatitis B in patients with evidence of viral replication and active liver inflammation were originally approved by FDA in October, 2006.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration