Sunday, 01 November 2020

American Regent Introduces Tralement (trace elements injection 4*, USP)

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  • PRN | 15 days ago
MELVILLE, N.Y: American Regent, Inc. announces the introduction of Tralement (trace elements injection 4*, USP), the first and only FDA-approved multi-trace element injection.

TralementTM is indicated in adult and pediatric patients weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.

We are pleased to offer the first FDA-approved multiple trace elements injection, which has been specifically developed to align with the American Society for Parenteral and Enteral Nutrition (ASPEN) recommendations for trace element supplementation.3 The concentration of each element in new TralementTM has been formulated to meet the needs of a broad range of patients, stated Joann Gioia, Associate Vice President, Commercial Operations and National Accounts at American Regent, Inc. This launch demonstrates American Regent's commitment to meeting the high bar of a new drug approval, and also serves to address the FDA's safety initiative for unapproved products.4

Looking forward, American Regent has committed to addressing the needs of special patient populations through the expansion of the Tralement product line. In addition, American Regent has made significant investments in its manufacturing infrastructure to help ensure a continuous supply of TralementTM.

American Regent Introduces Tralement (trace elements injection 4*, USP)

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