Global pharmaceutical company, Lupin Limited, announced today that the United States Food and Drug Administration (FDA) has tentatively approved its Abbreviated New Drug Application (ANDA) for Sodium Sulphate, Magnesium Sulphate, and Potassium Chloride Tablets, 1.479 g/0.225 g/0.188 g. These pills are a generic version of Braintree Laboratories Inc.'s Sutab pills (1.479 g/0.225 g/0.188 g).
Lupin is the exclusive first-to-file for this product, allowing the company to possibly gain 180 days of market exclusivity. Lupin's Nagpur plant in India will produce the tablets.
As part of the preparation for an adult colonoscopy, doctors recommend authorised tablets for colon cleansing. According to Lupin, the reference-listed drug (RLD), Sutab, has projected annual sales of USD 148 million in the United States as of May 2024, based on IQVIA statistics.
Lupin's provisional clearance is crucial to growing its generic pharmaceutical portfolio in the United States market.
