FDA C'tee Gives Thumbs Down For OTC Zovirax

Wellcome received a set-back last week, when the US Food and Drug Administration's Non-prescription Drugs and Antiviral Advisory Committee turned down its application for approval to market its antiviral Zovirax (aciclovir) in oral formulation as an over-the-counter product, for the treatment of genital herpes. OTC sales of Zovirax in the USA have been forecast to reach around $400 million in due course, which would have been a significant boost for total sales (amounting to L1.1 billion [$1.72 billion] in 1993).

In reviewing the Burroughs Wellcome application, the joint advisory committee - in a vote of 17 to one - concluded that it could not support the approval at this time. Although Wellcome says it had hoped for an affirmative recommendation from the meeting, it believes the committee's request for more information is consistent with other recent advisory committee reviews.

Despite the negative outcome of the committee's meeting, Wellcome contends that it remains committed to the conversion of Zovirax 200mg as an OTC product for the management of recurrent genital herpes and plans to move quickly to discuss next steps with the FDA.