adefovir dipivoxil
Drug Details
- Generic Name
- adefovir dipivoxil
- Brand Names
- Adefovir dipivoxil
- Application Number
- ANDA205459
- Sponsor
- Apotex Corp.
- NDC Codes
- 1
- Dosage Forms
- TABLET
- Routes
- ORAL
- Active Ingredients
- ADEFOVIR DIPIVOXIL
Indications and Usage
1 INDICATIONS AND USAGE Adefovir Dipivoxil Tablets are indicated for the treatment of chronic hepatitis B in patients 12 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. This indication is based on histological, virological, biochemical, and serological responses in adult patients with HBeAg+ and HBeAg- chronic hepatitis B with compensated liver function, and with clinical evidence of lamivudine-resistant hepatitis B virus with either compensated or decompensated liver function. For patients 12 to less than 18 years of age, the indication is based on virological and biochemical responses in patients with HBeAg+ chronic hepatitis B virus infection with compensated liver function. Adefovir Dipivoxil Tablets are nucleotide analogues indicated for the treatment of chronic hepatitis B in patients 12 years of age and older. ( 1 )