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www.fdanews.com/articles/178838-novartis-to-pay-35m-to-settle-off-label-promotion-suit-for-eczema-therapy-elidel

Novartis to Pay $35M to Settle Off-Label Promotion Suit for Eczema Therapy Elidel

October 12, 2016

Novartis will pay more than $35 million to the U.S. and state governments to settle off-label promotion charges over the company’s marketing of its eczema cream, Elidel, for use on infants.

The deal marks the end to a whistleblower suit filed in 2006 by former Novartis sales representative Donald Galmines, who had accused Novartis of promoting and selling Elidel as a first-line treatment for children under 2 from February 2002 to April 2009. Eight states later joined an amended version of the complaint in March 2015.

The deal allows Novartis to maintain its innocence and requires that the company pay each state roughly $4,371 plus interest and more than $30 million to the U.S.

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