Lupin gets FDA nod to market ulcerative colitis tablets in US

Lupin has received tentative approval from the US health regulator to market its Balasalazide Disodium tablets, used for the treatment of ulcerative colitis, in the American market.

The company has received tentative approval to market its Balasalazide Disodium tablets 1.1 gm from the United States Food and Drug Administration (USFDA), Lupin said in a BSE filing today.

The company’s product is generic version of Salix Pharmaceuticals Inc’s Giazo tablets in the same strength, it added.

“Giazo tablets had US sales of $0.79 million (IMS MAT September 2016),” Lupin said.

Balasalazide Disodium tablets are indicated for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older, it added.

Shares of Lupin were trading 0.44 per cent up at Rs 1,458.50 apiece on the BSE.