Friday, February 15, 2013

Reuters: Regulatory News: US FDA okays Novartis drug to prevent liver transplant rejection

Reuters: Regulatory News
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US FDA okays Novartis drug to prevent liver transplant rejection
Feb 15th 2013, 23:21

Fri Feb 15, 2013 6:21pm EST

Feb 15 (Reuters) - U.S. regulators approved Novartis AG's Zortress as the first new drug in more than a decade for preventing organ rejection in adult patients receiving a liver transplant, the company said on Friday.

The immune system drug, also known as everolimus, is already approved by the Food and Drug Administration for preventing organ rejection for kidney transplant patients.

Regulators in Europe, where the drug is known as Certican, approved the liver transplant indication last October. The drug is sold in more than 90 countries to prevent organ rejection for renal and heart transplant patients, Novartis said.

Everolimus is also sold in different dosage strengths for uses in non-transplant patients under the brand names Afinitor and Votubia.

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