FDA Approves Flublok Quadrivalent
October 11, 2016 - The U.S. FDA approved a quadrivalent (effective against four different influenza strains) formulation of its Flublok® (influenza vaccine), manufactured by Protein Sciences Corporation. Flublok Quadrivalent is indicated for adults 18 and older. Flublok Quadrivalent contains more active antigens than other flu vaccines available in the U.S. therefore, it may provide better protection than vaccines with fewer antigens, particularly for individuals who are 50 and older and patients with immunocompromising conditions. Additionally, all Flublok vaccines are recombinant, they are made in cultured cells without antibiotics, animal cells, eggs, live influenza virus or preservatives. Flublok Quadrivalent will be launched next year in pre-filled, single-dose syringes for intramuscular (IM) injection.
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 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.