Par Pharmaceutical announced that the FDA has granted final approval for its Abbreviated New Drug Application (ANDA) for Glipizide Extended-Release Tablets, the generic version of Pfizer’s Glucotrol XL.
Glucotrol XL is a 2nd generation sulfonylurea indicated as adjunct to diet in type 2 diabetes. Glipizide appears to lower blood glucose acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets.
Two extrapancreatic effects shown to be important in the action of glipizide are an increase in insulin sensitivity and a decrease in hepatic glucose production.
Glipizde Extended-Release Tablets are available in 5mg and 10mg strengths. Par Pharmaceutical has begun shipping this product.
For more information call (800) 828-9393 or visit ParPharm.com.