Laurus Lab gets CDSCO panel nod to Manufacture, Market HIV drug Dolutegravir Sodium Oral Film
New Delhi: In line with the bioequivalence study data presented by drug maker Laurus Lab, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization(CDSCO) has granted approval to manufacture and market the anti-retroviral drug Dolutegravir Sodium Oral Film 5mg/10mg indicated in combination with other antiretroviral agents for the treatment of HIV-infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3Kg.
HIV (human immunodeficiency virus) is a virus that attacks the body's immune system. If HIV is not treated, it can lead to AIDS (acquired immunodeficiency syndrome). HIV damages the immune system and interferes with the body's ability to fight infection and disease. HIV can be spread through contact with infected blood, semen, or vaginal fluids. There's no cure for HIV/AIDS, but medications can control the infection and prevent disease progression.
Dolutegravir is an HIV-1 antiviral agent. It inhibits HIV integrase by binding to the active site and blocking the strand transfer step of retroviral DNA integration in the host cell. The strand transfer step is essential in the HIV replication cycle and results in the inhibition of viral activity.
At the recent SEC meeting for Antimicrobial and Antiviral held on 23rd December 2022, the expert panel reviewed the bioequivalence (BE) study data of the anti-retroviral drug Dolutegravir Sodium Oral Film 5mg/10 mg.
