Dr. Reddy’s Laboratories announced the launch of Valganciclovir Tablets, the generic version of Valcyte.
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Endo announced the launch of Valganciclovir Tablets, the first generic version of Roche’s Valcyte to be available in the U.S.
Endo announced that Qualitest, its subsidiary, has received final approval from the Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Valganciclovir Tablets, the generic version of Roche’s Valcyte.
Cytovene-IV is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor.
The NDA submission is supported by data from the multicenter, randomized, open-label, active-controlled phase 3 TAK-620-303 (SOLSTICE) trial.
Foscarnet sodium injection is indicated to treat cytomegalovirus retinitis in patients with AIDS and acyclovir-resistant mucocutaneous HSV in immunocompromised patients.
Livtencity is an orally bioavailable anti-CMV compound that targets and inhibits the UL97 protein kinase and its natural substrates.
Maribavir is an orally bioavailable anti-CMV compound that targets and inhibits the UL97 protein kinase and its natural substrates.
The new approvals include Besremi, Fyarro, Livtencity, Voxzogo, and Vuity.
The discontinuation is not due to manufacturing, product quality, safety or efficacy concerns.