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Boxed Warning to Be Added For Asthma Drug Omalizumab

Genentech has been instructed to add a boxed warning to its product label for omalizumab (Xolair), which is used to treat patients with asthma related to allergies.

The warning emphasizes that this medication may cause anaphylaxis. The FDA has also asked Genentech to revise the label and provide a medication guide for patients to strengthen the existing warning for anaphylaxis.
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Omalizumab was approved in 2003 to treat adults and adolescents with moderate-to-severe persistent asthma who tested positive for a perennial aero-allergen (pollen, grass, or dust) and whose symptoms were inadequately controlled with inhaled steroids.

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