Xolair gets black box labeling

Share this article:

The FDA has announced new "black box" labeling for Genentech's Xolair (omalizumab) to address the risk of anaphylaxis in patients using the asthma drug.

The new labeling, the FDA’s strictest, indicates that patient reports following the drug's approval in 2003 through 2006 noted cases of anaphylaxis were seen in roughly two out of 1000 patients.

Genentech collaborates with Novartis on the marketing of Xolair, which had $425 million in global sales last year.


 

Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

More in News

Judge blocks FDA bid to allow generic Precedex

Judge blocks FDA bid to allow generic Precedex

The US District Court for Maryland granted Hospira a temporary restraining order (TRO) against FDA, after the agency determined that potential generic competitors of the company's injectable sedation drug Precedex ...

GSK drug gets aplastic anemia indication

GSK drug gets aplastic anemia indication

Promacta was previously indicated for chronic immune thrombocytopenia.

Five things for Pharma Marketers to know: Wednesday, August 27

Five things for Pharma Marketers to know: Wednesday, ...

Allergan sets a shareholder voting date, Novo describes the types of acquisitions it will consider, and the AstraZeneca-Pfizer talks can now reopen.