Glucotrol is indicated as an adjunct to diet for the control of hyperglycemia and the associated symptomatology in patients with non-insulin-dependent diabetes mellitus type-2 diabetes.
Caraco Pharma will manufacture and market both 5mg and 10mg tablets. The company said it plans to begin marketing these strengths in the US immediately.
“We are pleased to gain this approval and add this to our growing portfolio of products that we market in the US. Glipizide will complement our current product mix by adding another anti-diabetic to our line,” said Daniel Movens, Caraco’s CEO.
“This approval brings our total marketed product selection to 21 different products represented by 45 strengths,” he added.