Posted from: Monday, April 06, 2015 - 09:57 AM - Present

Approval for Quadracel

March 25, 2015 – The U.S. Food and Drug Administration (FDA) approved Quadracel, manufactured by Sanofi Pasteur.  Quadracel combines diphtheria, tetanus toxoids, acellular pertussis absorbed, and inactivated poliovirus (DTaP-IPV) vaccine. Quadracel is indicated for use in children age four years through six years as an active vaccination.  This new quadruple vaccine is expected to help reduce the number of injections children need to meet the immunization schedule recommended by the Centers for Disease Control and Prevention (CDC). Quadracel is administered as one intramuscular (IM) injection and Sanofi suggests that it be used as the fifth dose for DTaP and the fourth for IPV. 

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.

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.


Last Updated Sunday, September 22, 2019 - 12:28 AM.