Syntex' Oral Ganciclovir Approved In the USA

Syntex Corp has received marketing clearance from the US Food and Drug Administration for Cytovene (ganciclovir capsules) for oral administration. The product will be marketed in the USA by Syntex' parent Hoffmann-La Roche, which also markets the intravenous formulation of the drug, Cytovene IV. The FDA designated the drug 3P, meaning a new dosage form given priority review. It was first approved in the UK in December 1994, and marketing applications are pending in 13 countries.

The capsule form of Cytovene is indicated "as an alternative to the intravenous formulation for the maintenance treatment of cytomegalovirus retinitis in immunocompromized patients, including those with AIDS, whose retinitis is stable following appropriate intravenous induction therapy," according to the company.

A boxed warning in the labeling for the drug notes that because oral ganciclovir is associated with a risk of more rapid disease progression, it should be used "only in those for whom the risk of more rapid disease progression is balanced by the benefit associated with avoiding daily intravenous infusions," according to the company. The recommended dose for Cytovene capsules is 1,000mg three times daily or 500mg six times daily.