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The FDA declined to comment on the status of the medication’s approval, but NIAID and the two drugmakers announced recently that the FDA had granted priority review for Xolair.
The US Food and Drug Administration on Friday approved a medication called Xolair to help lessen the severity of an accidental allergic reaction in people who are allergic to multiple foods.
Omalizumab, sold under the brand name Xolair among others, is an injectable medication to treat severe persistent allergic forms of asthma, nasal polyps, urticaria (hives), [10] [11] and immunoglobulin E-mediated food allergy.
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall. [1]
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
FDA Files Genentech's Supplemental Biologics License Application of Xolair ® (omalizumab) for Chronic Idiopathic Urticaria (CIU) CIU is a skin condition characterized by red, swollen, itchy hives ...
Approvable letters were issued to applicants at the end of the FDA's review period to indicate that the application or abbreviated application is basically approvable providing certain issues are resolved. It was an indication that the application substantially met FDA requirements if specific conditions, such as labeling changes, are agreed to.
The recall is a correction, not a product removal, the FDA said. "This notification is not a device removal and Impella heart pumps remain on the market and available for patients," a J&J ...