The estimated user fee deadline for Sanofi-Aventis' meningococcal conjugate vaccine Menactra has passed without word of the product's approval status from the company.

Aventis Pasteur submitted the BLA on Dec. 18, 2003, setting a user fee review goal of Oct. 18.

FDA said Oct. 20 that Menactra is not currently a licensed product in the U.S.; the agency declined to provide further information about the application.

Sanofi-Aventis has not announced an action by FDA.

During a Sept. 22 meeting, FDA's Vaccines & Related Biological Products Advisory Committee unanimously concluded that Menactra was shown to be non-inferior to Menomune with regard to immunogenicity and safety (¹ Also see "Sanofi-Aventis' Menactra Post-Approval Commitments Should Include Long-Term Safety, Efficacy Data" - Pink Sheet, 22 September, 2004.).

However, committee Chairman Gary Overturf, MD, recently suggested the Menactra approval may be delayed by an FDA request for further data from Sanofi-Aventis (² Also see "Menactra May Require More Data For Approval, Advisory Committee Chair Says" - Pink Sheet, 8 October, 2004.).

- Sue Sutter

Where’s Menactra? No Word From Sanofi-Aventis As User Fee Date Passes

More from Archive

More from Pink Sheet