The drug, entecavir, is taken orally and is designed to work by preventing the virus that causes the illness from reproducing.
The chronic form of hepatitis B can permanently damage the liver and lead to cirrhosis and liver cancer.
Entecavir is made by Bristol-Myers Squibb and will be sold under the trade name Baraclude. The company said it could be available in early April.
Current treatment options for chronic hepatitis include interferon, given by injection, and two drugs administered orally, lamivudine and adefovir dipivoxil.
The Hepatitis B Foundation estimates that 1.2 million Americans have hepatitis B and another 100,000 are infected annually.
In clinical trials the main side effects reported for the drug were headache, tiredness, dizziness and nausea.