Zydus Gets CDSCO Panel Nod To Manufacture Market Letermovir 240 mg, 480 mg Tablet
New Delhi: The drug major Zydus has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market Letermovir 240 mg and 480 mg tablets with Phase-III clinical trial waiver.
However, this nod is subject to the condition that Zydus should submit the Phase-IV clinical trial (CT) protocol to CDSCO within three months of the grant of permission.
Furthermore, the expert panel suggested that the drug product be sold on the prescription of specialists in organ transplant, infectious disease, hematologist, etc.
This came after Zydus presented the proposal for a grant of permission to manufacture and market Letermovir tablets 240mg and 480 mg with a Phase-III clinical trial waiver request, along with a bioequivalence (BE) study report.
Letermovir is an antiviral medication used for prophylaxis in adult transplant recipients at risk of cytomegalovirus (CMV) infection and disease.
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