Pharma Major Lupin has received tentative approval for its Balasalazide Disodium Tablets, 1.1 gm from the United States Food and Drug Administration (USFDA) to market a generic version of Salix Pharmaceuticals Inc's Giazo Tablets, 1.1 gm. The filing is from company's Goa manufacturing facility.
The company’s Balasalazide Disodium tablets 1.1 gm are the AB rated generic equivalent of Salix Pharmaceuticals Inc's Giazo Tablets, 1.1 gm. Balasalazide Disodium tablets are indicated for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older. Giazo Tablets had US sales of $0.79 million as per IMS MAT September 2016.
Lupin is a pharmaceutical company and is engaged in formulation of drugs and active pharmaceutical ingredients (APIs), generics, biotechnology, novel drug discovery and development, drug delivery systems and specialty pharmaceuticals.
