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Hiberix FDA Approval History

FDA Approved: Yes (First approved August 19, 2009)
Brand name: Hiberix
Generic name: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
Dosage form: Solution for Intramuscular Injection
Company: GlaxoSmithKline
Treatment for: Haemophilus influenzae Prophylaxis

Hiberix is a vaccine indicated for active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b. Hiberix is approved for use in children aged six weeks through four years of age (prior to fifth birthday).

Development timeline for Hiberix

Jan 14, 2016Approval FDA Approves Expanded Use of GSK Hib Vaccine From Booster Dose To Full Series
Aug 20, 2009Approval FDA Approves GSK's Hib Vaccine, Hiberix

Further information

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