Menactra user fee deadline passes

Estimated Oct. 18 user fee deadline for Sanofi-Aventis' meningococcal conjugate vaccine Menactra passes without word of the product's approval status from the company. FDA says Menactra is not currently licensed in the U.S. but declines to provide further information about the BLA. In September, an FDA advisory committee concluded that Menactra was non-inferior to Menomune with regard to immunogenicity and safety (1"The Pink Sheet" Sept 27, 2004, p. 36). However, the committee's chairman recently suggested approval may be delayed by an FDA request for further data from Sanofi-Aventis...

Estimated Oct. 18 user fee deadline for Sanofi-Aventis' meningococcal conjugate vaccine Menactra passes without word of the product's approval status from the company. FDA says Menactra is not currently licensed in the U.S. but declines to provide further information about the BLA. In September, an FDA advisory committee concluded that Menactra was non-inferior to Menomune with regard to immunogenicity and safety (¹ (Also see "Menactra Needs Long-Term Safety, Efficacy Studies Post-Approval – Cmte." - Pink Sheet, 27 Sep, 2004.), p. 36). However, the committee's chairman recently suggested approval may be delayed by an FDA request for further data from Sanofi-Aventis....