FDA gives Genentech’s asthma drug black box label

The FDA originally proposed its “black box warning” about anaphylaxis back in February. The label’s final wording has only recently been announced.

Xolair, which is known generically as omalizumab, is approved to treat adults and children over the age of 12 for moderate to servere asthma.

The drug’s previous label warned that anaphylaxis, an inflammatory reaction, occurs in roughly one in 1,000 patients. The new label now states the figure is two out of 1,000 patients taking the medication.