FDA gives Lupin tentative OK for generic Sutab
Lupin has received tentative approval from the Food and Drug Administration for sodium sulfate, magnesium sulfate and potassium chloride tablets, 1.479 g/0.225 g/0.188 g, which is a generic of Braintree’s Sutab.
Lupin is the exclusive first-to-file for this product and may be eligible to receive a 180-day exclusivity. This product will be manufactured at Lupin’s Nagpur facility in India.
Sodium sulfate, magnesium sulfate and potassium chloride tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults.
[Read more: Lupin receives FDA nod for 3 generics]
Sodium sulfate, magnesium sulfate and potassium chloride tablets had a market value of $48 million, per May 2024 data.
[Read more: Lupin receives FDA nod for generic Lotemax]