Xolair Indication Expanded
July 7, 2016 – The U.S. FDA approved Xolair® (omalizumab) manufactured by Genentech with an expanded indication to treat moderate to severe allergic asthma in patients six years of age and older who are inadequately controlled with inhaled corticosteroids. Xolair was previously approved for this indication in patients 12 years of age and older. On the market since 2003, Xolair is administered by subcutaneous injection. It is also indicated to treat chronic idiopathic urticaria in patients 12 years of age and older who have symptoms despite treatment with an H1 antihistamine.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.