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Tagged With "Xolair"

Blog Post

FDA Will Consider Xolair for the Treatment of Nasal Polyps

AAFA Community Services ·
Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids.
Blog Post

FDA Accepts Biologics License Application for Xolair® Prefilled Syringe for Self-Administration

AAFA Community Services ·
Novartis today announced that the US Food and Drug Administration (FDA) accepted the company's supplemental Biologics License Application (sBLA) for a new self-administration option for Xolair® (omalizumab) across all approved US indications. If approved, Xolair prefilled syringe would become available for either self-administration by select patients or administration by their caregivers.
Blog Post

FDA Approves Xolair® (Omalizumab) Prefilled Syringe for Self-Injection

AAFA Community Services ·
Novartis today announced that the US Food and Drug Administration (FDA) approved the supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection in appropriate patients across all approved US indications.1 Xolair is the only FDA-approved biologic designed to target and block immunoglobulin E (IgE) for the treatment of moderate to severe persistent allergic asthma, chronic idiopathic urticaria (CIU) and nasal polyps.
Comment

Re: FDA Approves Xolair® (Omalizumab) Prefilled Syringe for Self-Injection

Kathy P ·
If you are currently on Xolair or considering it, what are your thoughts about self injections? Excited that this will make things more convenient? Apprehensive about doing the shots at home instead of a clinic? Join the discussion !
Comment

Re: FDA Approves Xolair® (Omalizumab) Prefilled Syringe for Self-Injection

katalinfrog ·
I've been on Xolair injections for 8 months now, and we're doubling my dose since my IgE levels are still very high. Even though the FDA has approved injecting at home, my physician's office is still apprehensive about allowing me to inject at home. I have Epi pens and I'm ready to make the switch. It will save me an hour round trip, and $65 per injection. Is it typical for doctor's offices to be nervous about switching?
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