Bristol-Myers Squibb and partner sanofi-aventis are voluntarily withdrawing certain lots of AVALIDE® (irbesartan-hydrochlorothiazide) from the U.S., Puerto Rican, Canadian, Mexican and Argentinean markets. Supply of AVALIDE to these markets will be affected indefinitely. Bristol-Myers Squibb is recalling all lots produced at its Humacao, Puerto Rico, facility and four batches produced at our Evansville, Indiana, facility in which this less soluble form of irbesartan has been found.
We are working with our partner sanofi-aventis to identify all possible solutions to this issue, including process adjustments and alternate supply sources; however, these solutions are complex and will take time to assess.
Sales for AVALIDE for the first three quarters of 2010 in the affected markets were approximately $310 million.
AVALIDE is a combination product and patients can take AVAPRO® (irbesartan) plus HCTZ separately to achieve a similar level of blood pressure control as the combination product. To support patients in the U.S., Bristol-Myers Squibb will make vouchers available to help defray the cost of hydrochlorothiazide. We expect that the availability of these vouchers will enable many patients to continue to benefit from the combination of AVAPRO plus HCTZ ...more
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