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FDA recall of Omontys (Affymax/Takeda) for treatment of Anaemia in adult dialysis patients

Read time: 1 mins
Last updated: 28th Feb 2013
Published: 28th Feb 2013
Source: Pharmawand

The FDA is alerting health care providers and patients of a voluntary nationwide recall of all lots of Omontys Injection (peginesatide) by Affymax, Inc., and Takeda Pharmaceuticals Company Limited. The recall is due to reports of anaphylaxis, a serious and life-threatening allergic reaction. Omontys is used to treat anemia in adult dialysis patients.

Omontys was filed last year at EMA for treatment of symptomatic anemia associated with Chronic Kidney Disease (CKD) in adult patients on dialysis.

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