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Pharmaceutical firm Lupin on Monday said it has received tentative approval from the US health regulator to market its generic version of Dolutegravir and Rilpivirine tablets used in treatment of HIV infection. The tentative approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Dolutegravir and Rilpivirine tablets of strength 50 mg/25 mg, Lupin said in a regulatory filing. The Dolutegravir and Rilpivirine tablets, 50 mg/25 mg had estimated annual sales of USD 666 million in the US, the company said citing IQVIA MAT September 2022 data.
Three doses of HEPLISAV-B vaccine provide full protection to adults with HIV, who were never immunised against hepatitis B virus (HBV) either through vaccination or infection, according to a study. In the research presented at the annual IDWeek conference held in Washington, US from October 19 to 23, the researchers from University of Cincinnati and Cornell University tested the three-dose course of HEPLISAV-B among 68 adults living with HIV at 38 sites in the US, South Africa, and Thailand. None of the participants had either received a previous HBV vaccination or had evidence of a previous HBV infection - all were on antiretroviral therapy to combat infection by retroviruses such as HIV. Retroviruses are a group of viruses that contain two single-strand linear RNA molecules per virion, or a viral particle, and reverse transcriptase (RNA to DNA). Following the initial dose of HEPLISAV-B vaccine 0.5 milliliter (mL) as an intramuscular injection, the study participants received ...
Drug firm Lupin on Tuesday said it has received an approval from the US health regulator to market Darunavir Tablets, used to treat Human Immunodeficiency Virus (HIV) infection, in the American market. The Mumbai-based company said it is the exclusive first filer for 800 mg tablets and is eligible for 180-day exclusivity. Lupin will also potentially have shared 180-day exclusivity on the 600 mg tablets, it added. The company has received the approval from the US Food and Drug Administration (USFDA) for the medication in strengths of 600 mg and 800 mg, Lupin said. The drug firm's product is a generic equivalent of Janssen Products' Prezista Tablets. As per MAT June 2022 data, Darunavir tablets (600 mg and 800 mg) had estimated annual sales of USD 343 million in the US. Lupin shares were trading 2.17 per cent up at Rs 738.30 apiece on the BSE.