Tyrvaya Becomes First FDA-Approved Nasal Spray for Dry Eye Disease
October 18, 2021Merck Recalls One Lot of Intravenous Antibiotic
October 19, 2021October 18, 2021 – Gilead's Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide) has received an expanded indication to treat HIV-1 in children who weigh 14kg (31 pounds) to less than 25kg (55 pounds) and are either virologically suppressed or new to antiretroviral therapy. The FDA also approved a new, lower dosage form of the drug for use in this patient population.
- Originally FDA approved in 2018 to treat adults, Biktarvy has been approved since 2019 to treat children who weigh at least 25kg.
- The new lower dosage form is an oral tablet that offers a complete antiviral treatment regimen. It contains 30mg of bictegravir, 120mg of emtricitabine, and 15mg of tenofovir alafenamide. Recommended dosing is one tablet daily for children weighing 14kg to 25kg.
- Adults and children who weigh at least 25kg should take the higher dosage form tablet once daily. It contains 50mg of bictegravir, 200mg of emtricitabine, and 25mg of tenofovir alafenamide.