Strides Pharma Science Limited (Strides) announced that its Singapore-based stepdown wholly owned subsidiary, Strides Pharma Global Pte. Limited, has received tentative approval for Dolutegravir 50mg tablets from the United States Food & Drug Administration (FDA). The tentative approval, which deems the Dolutegravir 50mg tablets bioequivalent and therapeutically equivalent to Tivicay Tablets of ViiV Healthcare Company, […]
Aurobindo Pharma Limited has achieved a significant milestone by securing the US Food and Drug Administration (FDA)’s tentative nod under the PEPFAR program for its generic dispersible tablet, a fixed-dose combination of Abacavir 60mg, Lamivudine 30 mg, and Dolutegravir 5 mg (pALD). This formulation is pivotal for treating children afflicted with HIV, particularly those weighing […]
Lupin Limited, a leading global pharmaceutical company, has received tentative approval for its New Drug Application (NDA) for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets from the US Food and Drug Administration (US FDA). The approval, granted under the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), gives Lupin the green light to manufacture the product […]
Indian pharmaceutical company Lupin announced that the US Food and Drug Administration (FDA) has granted tentative approval for its Abbreviated New Drug Application (ANDA) for Dolutegravir Tablets for Oral Suspension, 5 mg. This approval will allow Lupin to market a generic equivalent of ViiV Healthcare’s Tivicay PD Tablets for Oral Suspension, 5 mg. The tablets […]
Lupin Limited has been granted tentative approval by the US Food and Drug Administration (FDA) for its new drug application (NDA) for HIV drug cocktail – Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate (TLD) Tablets, 50 mg/300 mg/300 mg, and antiretroviral fixed-dose combination (FDC). The TLD product, which has been approved under the US President’s Emergency […]
Dovato EMA approval : The European Commission (EC) has approved ViiV Healthcare’s once-daily, single-pill, two-drug regimen Dovato (dolutegravir/lamivudine) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Dovato EMA approval The European approval for Dovato is for adults and adolescents aged over 12 years, weighing more than 40 kg, with no known or […]
In the latest pharma industry news, ViiV Healthcare has bagged Juluca FDA approval for the maintenance treatment of virologically suppressed HIV-1 infection.
ViiV Healthcare, a joint venture between GlaxoSmithKline (GSK), Pfizer, and Shionogi, has received approval from the U.S. Food and Drug Administration (FDA) for its two-drug regimen, Juluca, for the maintenance treatment of adults with virologically suppressed human immunodeficiency virus type 1 (HIV-1). This groundbreaking treatment, composed of dolutegravir 50mg and rilpivirine 25mg, is the first […]