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FDA Requests Testosterone Gel Name Change, Announcing Fortigel
Yesterday, Cellegy Pharmaceuticals, Inc. announced that following a request by the Food and Drug Administration (FDA), Cellegy changed the trade name of its lead drug, Tostrex(TM) Gel to Fortigel(TM). The name change was made in response to the FDA's observation that the original name could potentially create confusion on the part of medical professionals and consumers when compared with currently marketed products.
Fortigel is a unique, proprietary transdermal testosterone gel, utilizing a metered dose delivery system, for the treatment of male hypogonadism, a condition which afflicts up to 5 million men in the United States, primarily over the age of forty. Male hypogonadism is frequently characterized by reduced libido, loss of muscle mass and bone density, and diminished energy levels. Based on current estimates, domestic sales of all testosterone products are $250 to $300 million per year.