Cipla Gets CDSCO Panel Nod To Manufacture, Market HIV drug
New Delhi: Pharmaceutical major, Cipla has got the green signal from the Subject Expert Committee (SEC)functional under Central Drug Standard Control Organization (CDSCO) to manufacture and market the fixed-dose combination (FDC) drug Bictegravir 50mg plus Emtricitabine 200mg plus Tenofovir alafenamide 25mg indicated for the treatment of HIV type 1 (HIV-1) infection in adults.
However, this approval is subject to the condition that the drug major Cipla should conduct a Phase IV clinical trial in the country with an adequate number of subjects for which protocol should be submitted to CDSCO within three months from the date of approval of the drug for further review
This came after the firm presented the proposal to manufacture and market the FDC Bictegravir 50mg plus Emtricitabine 200mg plus Tenofoviralafenamide 25mg.
Bictegravir is in a class of medications called integrase strand transfer inhibitors (INSTIs). Emtricitabine and tenofovir AF are in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs).
Emtricitabine is in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). It works by decreasing the amount of HIV in the blood.
Tenofovir is in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). It works by decreasing the amount of HIV and HBV in the blood.
Bictegravir, emtricitabine, and tenofovir alafenamide are combined to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).
At the recent SEC meeting Antimicrobial & Antiviral held 25th April 2023, the expert panel reviewed the proposal to manufacture and market the FDC Bictegravir 50mg plus Emtricitabine 200mg plus Tenofoviralafenamide 25mg.
After detailed deliberation, the committee recommended the grant of permission to manufacture and marketing of FDC of Bictegravir, Emtricitabine, Tenofovir alafenamide subject to the condition that the firm should conduct a Phase IV clinical trial in the country with an adequate number of subjects for which protocol should be submitted to CDSCO within three months from the date of approval of the drug for further review by the committee.
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