Lupin obtains tentative nod from FDA for generic Jynarque
Jynarque is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease.
Lupin has received tentative approval from the Food and Drug Administration for Tolvaptan tablets, 15 mg, 30 mg, 45 mg, 60 mg and 90 mg, which is a generic of Otsuka Pharmaceutical’s Jynarque tablets.
Jynarque is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease.
[Read more: Lupin receives FDA OK for generic Banzel]
This product will be manufactured at Lupin’s Nagpur facility in India.
Tolvaptan (Jynarque) tablets had a market value of roughly $287 million, per IQVIA August 2023 data.
[Read more: Lupin receives FDA OK for generic Derma Smoothe/FS]