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Covidien Submits Label Change For Optimark Contrast Agent - Quick Facts

Covidien Plc (COV) stated that it will voluntarily contraindicate the use of its Optimark gadoversetamide injection, a gadolinium-based contrast agent or GBCA, in magnetic resonance imaging or MRI procedures involving patients with severe renal impairment. The company said it is modifying the product's label to reflect a contraindication for this small patient population, which constitutes less than 0.5% of the U.S. population.

Mallinckrodt Inc., a Covidien company, submitted this label change to the U.S. Food and Drug Administration (FDA) and is implementing the new label in the U.S. effective immediately. The company added that it is implementing this label change in all other countries, where Optimark contrast agent has been approved for sale, in accordance with local regulatory requirements.

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