Lupin receives FDA approval for Tolvaptan tablets

6 Oct 2023 , 12:13 PM

The U.S. Food and Drug Administration has given the pharmaceutical company Lupin preliminary clearance for its abbreviated new drug application (ANDA) for Tolvaptan tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg.

The drug, a generic version of the Jynarque 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg tablets from Otsuka Pharmaceutical Co., is intended to prevent the rapid deterioration in kidney function in individuals who are at risk for autosomal dominant polycystic kidney disease (ADPKD). Lupin will produce the product at its Nagpur facility.

According to data from IQVIA MAT for August 2023, tolvaptan tablets (RLD Jynarque) had expected annual sales of $287 million in the U.S.

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