Subject: Viratek Withdraws Request for Approval Of Drug in AIDS Use
Date: Published: 11/13/89 (38 lines)
Source:  Wall Street Journal.  Copyright Dow Jones & Co. Inc. 

    Technology:
    Viratek Withdraws
    Request for Approval
    Of Drug in AIDS Use

    COSTA MESA, Calif.  -- Viratek Inc. said it temporarily
 withdrew its request for government approval to distribute
 its drug ribavirin while it is being tested but expects to
 resubmit the application shortly.
    The drug would be used to treat certain patients who are
 infected with the acquired immune deficiency syndrome virus
 but show no symptoms of the disease.  The "Treatment IND"
 request, if approved by the FDA, would allow expanded
 distribution of the drug, which the FDA approved last April
 for large-scale testing.
    Currently, ribavirin is approved in the U. S. to treat
 infants with a respiratory infection, but for no other uses.
 It has been approved in other countries for a number of
 non-AIDS-related uses.
    The company said it made the announcement in response to
 news inquiries, and a spokesman declined to comment on the
 significance of the withdrawal.  The spokesman did say that an
 FDA deadline for approval had passed but the deadline had
 been extended when the company withdrew the application.
    Viratek is 74% owned by ICN Pharmaceuticals Inc., also
 based in Costa Mesa.
    Brad Stone, a spokesman for the FDA said, "If they apply
 again, we will consider the application on the basis of the
 merits.  We aren't going to prejudge it."

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