Central Drugs Standard Control Organisation’s (CDSCO) Technical Committee has recommended for the grant of permission to Bayer to import and market the drug rivaroxaban 2.5mg tablet without conducting mandatory local clinical trials.
India’s top drug regulatory authority, however, directed the German pharma giant to conduct a phase IV clinical trial and submit the protocol for the post marketing drug surveillance studies within three months of approval of the additional indication for review.
The recommendation came following the deliberation of the proposal presented by Bayer seeking import and marketing permission for the additional indication of rivaroxaban tablets 2.5mg with a request for waiver of a local clinical trial by CDSCO Committee.
Rivaroxaban 2.5mg tablet, administered along with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.
Bayer, in its proposal, mentioned the current status of international approvals of the drug. The European Medical Agency already approved rivaroxaban for the new indication way back in August 2010.
Rivaroxaban tablet 10mg is indicated for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.
Whereas rivaroxaban 15/20mg is indicated for the treatment of deep vein thrombosis and for prevention of recurrent DVT and pulmonary embolism and for the prevention of stroke and systemic embolism in a patient with non- valvular arterial fibrillation.
Rivaroxaban tablet 2.5mg administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers, according to CDSCO.