FDA: Hepatitis B Drug Discontinued

Not due to manufacturing, product quality, safety or efficacy concerns
Not due to manufacturing, product quality, safety or efficacy concerns

The Food and Drug Administration (FDA) has posted a discontinuation notice for Tyzeka (telbivudine; Novartis) film coated tablets. 

Tyzeka, a nucleoside analogue (reverse transcriptase inhibitor), is indicated to treat chronic hepatitis B in patients with evidence of viral replication and either evidence of persistent elevations of ALT/AST or histologically active disease.

Telbivudine is phosphorylated by cellular kinases to the active triphosphate form. This inhibits HBV DNA polymerase by competing with the natural substrate. Incorporation of telbivudine 5'-triphosphate into viral DNA causes DNA chain termination. 

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Tyzeka was supplied as 600mg strength film coated tablets in 30-count bottles (NDC 0078-0538-15). The discontinuation is not due to manufacturing, product quality, safety or efficacy concerns. Generic equivalents are not available but other therapeutic alternatives exist. 

For more information call (888) 669-6682 or visit Novartis.com.

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