You are here

FDA Requests Testosterone Gel Name Change, Announcing Fortigel

UPPER SADDLE RIVER, N.J., April 23 /PRNewswire-FirstCall/ -- PDI, Inc. (NASDAQ:PDII) -- On January 2, 2003, PDI announced that it had entered into an exclusive license agreement with Cellegy Pharmaceuticals, Inc. to commercialize Tostrex(TM) testosterone gel in North American markets.

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.

About Fortigel
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.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs
Acasti reports disappointing results for a second Omega-3-based drug
Declining lung cancer mortality helped fuel the progress