Novartis said it received permission to sell its new diabetes drug Galvus (Vildagliptin) in the European Union, which comes as a relief after the company recently said it may never launch the drug in the U.S.
Novartis, based in Basel, said the European Commission approved Galvus for the treatment of type 2 diabetes, in combination with some of the most frequently prescribed oral anti-diabetes medicines: metformin, sulphonylureas, or thiazolidinediones.
This regulatory approval comes after changes to the E.U. label - information on how and to whom the drug should be prescribed - were proposed by Novartis regarding the administration of Galvus.
Analysts expect that European sales of Galvus will amount to around $250 million to $400 million in the drug's best year.
Novartis said in January that Galvus, which it had hoped would become a multibillion-dollar product, may never get a U.S. launch. Novartis hoped to start selling the drug in the U.S. last year, but the Food and Drug Administration requested more clinical testing, delaying Galvus' launch indefinitely.
Novartis, based in Basel, said the European Commission approved Galvus for the treatment of type 2 diabetes, in combination with some of the most frequently prescribed oral anti-diabetes medicines: metformin, sulphonylureas, or thiazolidinediones.
This regulatory approval comes after changes to the E.U. label - information on how and to whom the drug should be prescribed - were proposed by Novartis regarding the administration of Galvus.
Analysts expect that European sales of Galvus will amount to around $250 million to $400 million in the drug's best year.
Novartis said in January that Galvus, which it had hoped would become a multibillion-dollar product, may never get a U.S. launch. Novartis hoped to start selling the drug in the U.S. last year, but the Food and Drug Administration requested more clinical testing, delaying Galvus' launch indefinitely.
