Bristol-Myers Squibb, Merck received an approval letter from FDA for pargluva
The US Food and Drug Administration (FDA) issued an approvable letter to
Bristol-Myers Squibb Company and Merck & Co. Inc for pargluva (muraglitazar), the companies' investigational oral medicine for the treatment of type 2 diabetes. The FDA has requested additional safety information from ongoing trials or those completed since the safety data from the last formal regulatory submission to address more fully the cardiovascular safety profile of pargluva.
In early September, Bristol-Myers Squibb researchers presented the pre-clinical and clinical data to support the benefit-risk profile of pargluva to the FDA's endocrinologic and metabolic drugs advisory committee claims a company release.
Bristol-Myers Squibb and Merck are collaborators in the global development and commercialisation of pargluva. The new drug application (NDA) for pargluva was submitted to the FDA in late December 2004.
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life. Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first.