Magazine article Drug Topics

Leap of Life

Magazine article Drug Topics

Leap of Life

Article excerpt

The Food & Drug Administration made good use of the extra day in February this year, approving two new drugs and one new formulation and recommending approval of several other drugs in the fight against AIDS. Here are highlights of the events that transpired in Washington during the last week of February and the first week of March:

* Seventy-two days after NDA submission, the FDA approved Abbott's Norvir (ritonavir). The protease inhibitor was granted full approval for patients with advanced HIV disease and accelerated approval for patients with less advanced disease. It is indicated as monotherapy or for use with a nucleoside analog, and it will be available as a liquid and as a capsule.

On March 5, the FDA cleared the Vitrasert Implant (Chiron Visions) for the treatment of cytomegalovirus retinitis in people with AIDS. This ophthalmic implant releases ganciclovir (Cytovene, Roche Laboratories) directly into the eye over a period of about six months. It has been shown to delay the progression of CMV retinitis.

The FDA approved a new formulation of Videx (didanosine, ddl, Bristol-Myers Squibb) tablets. The reformulated tablet is smaller, orange-flavored, and easily dispersible in water. …

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