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Novartis announces Aliskiren will continue to be available to appropriate patients, as FDA interim assessment is concluded; product information updated Full Text
Novartis, 04/20/2012
Novartis announced that the Tekturna labels have been updated in the US, following the US Food and Drug Administration's (FDA) review of the preliminary findings from the ALTITUDE study. The label change includes a contraindication against combined use of aliskiren–based products with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) in patients with diabetes. The FDA has also requested the inclusion of a warning against the use of aliskiren–based products in patients with moderate renal (kidney) impairment (eGFR < 60 ml/min) who are also taking an ACE inhibitor or an ARB.
