Teva Pharmaceutical Industries Ltd announced that the US Food and Drug Administration has granted tentative approval for the company's ANDA for Rosiglitazone Maleate Tablets, 2 mg, 4 mg and 8 mg. Final approval is expected upon the resolution of patent litigation.
Teva's Rosiglitazone Maleate Tablets are the AB-rated generic equivalent of SB Pharmaco's Avandia Tablets. This product is indicated as an adjunct to diet and exercise in the treatment of type 2 diabetes.
The brand product has annual sales of approximately $1.4 billion.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 25 pharmaceutical companies and among the largest generic pharmaceutical companies in the world.