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.
- 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.