FDA Approves Vitravene For CMV Retinitis
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FDA Approves Vitravene For CMV Retinitis

CARLSBAD, CA and ATLANTA, GA -- Aug. 27, 1998 -- The United States Food and Drug Administration has approved Isis Pharmaceuticals, Inc.’s and CIBA Vision Corp.’s new drug application for Vitravene(TM) (fomivirsen sodium injectable) for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS.

Vitravene is the first in a class of novel therapeutics based on antisense technology to be approved for marketing in the U.S. Vitravene is indicated for the local treatment of CMV retinitis in patients with AIDS who are intolerant of or have a contraindication to other treatments for CMV retinitis or who were insufficiently responsive to previous treatments for CMV retinitis. The recommended labelled dosage consists of an induction dose on days one and 15 followed by a monthly intravitreal injection of 330 mg (micrograms).

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