Viread tenofovir disoproxil fumarate regulatory update

FDA approved an sNDA from Gilead for once-daily 150, 200 and 250 mg oral tablets of Viread tenofovir disoproxil fumarate to treat HIV-1 infection in children ages 6-12 years. The nucleotide analog prodrug reverse transcriptase inhibitor is already available as a 300 mg dose to treat HIV-1 infection in patients ages >=12 years and to treat chronic HBV infection in adults. The product is also approved in the EU to treat HIV infection and HBV infection in adults with decompensated liver disease or in adults with compensated liver disease who have evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. ...