GSK Boostrix May Launch By June; FDA Wants Quick sBLA With Infanrix Cohort
Executive Summary
FDA is asking GlaxoSmithKline to submit a supplementary BLA for Boostrix with data on use of the tetanus, diphtheria and pertussis booster vaccine in patients who received a full course of the primary vaccine as part of its May 3 approval
You may also be interested in...
Sanofi’s Adacel Tdap Vaccine Receives Broader Approval Than GSK’s Boostrix
Sanofi-Aventis' postmarketing commitments for Adacel include a 16,000-patient epidemiologic safety surveillance study of the tetanus, diphtheria and acellular pertussis vaccine
Sanofi’s Adacel Tdap Vaccine Receives Broader Approval Than GSK’s Boostrix
Sanofi-Aventis' postmarketing commitments for Adacel include a 16,000-patient epidemiologic safety surveillance study of the tetanus, diphtheria and acellular pertussis vaccine
Boostrix, Adacel Get Advisory Cmte. Backing, But Postmarket Studies Urged
Postmarketing studies are needed to monitor the safety and effectiveness of GlaxoSmithKline's Boostrix and Sanofi Pasteur's Adacel in individuals who will receive only acellular primary pertussis vaccine, FDA's Vaccines & Related Blood Products Advisory Committee said March 15