FDA Approves Generic Hepatitis B Treatment

Entecavir treats chronic hepatitis B infection in adults with evidence of active viral replication.

A generic equivalent to Bristol-Myers Squibb’s entecavir (Baraclude) hepatitis B treatment has been approved by the FDA.

Aurobindo Pharma’s generic entecavir will soon be available in 0.5 mg and 1 mg oral tablet strengths. Entecavir is a nucleoside analogue indicated to treat chronic hepatitis B infection in adults with evidence of active viral replication, though it may also be used in patients who have shown either persistent elevations in serum aminotransferases or histologically active disease.

Entecavir does not cure chronic hepatitis B infection or prevent its spread. The drug’s labeling includes boxed warnings about exacerbations of hepatitis after treatment discontinuation, as well as lactic acidosis and severe hepatomegaly with steatosis.

Side effects associated with entecavir include headache, fatigue, dizziness, and nausea. They should be immediately reported to a health care professional, as well as the FDA’s MedWatch program.

Patients are also encouraged to speak with their health care provider before discontinuing the medication.