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FDA APPROVES ANDROGEL TO TREAT MALE TESTOSTERONE DEFICIENCY.


Unimed Pharmaceuticals, Inc., Buffalo Grove, Ill., has announced that AndroGel(TM) 1% (testosterone gel) (C-III C-III Schedule III Controlled Substance (USA) ) has been approved by the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
). The approval makes AndroGel(TM) the first-ever testosterone replacement gel to be approved by the FDA for replacement therapy in men for conditions associated with low testosterone. Low testosterone, also known as hypogonadism Hypogonadism Definition

Hypogonadism is the condition more prevalent in males in which the production of sex hormones and germ cells are inadequate.
, affects approximately four to five million American men. The condition is linked with diminished interest in sex, impotence, reduced lean body mass, decreased bone density and lowered mood and energy levels. AndroGel(TM) will be available with a prescription in pharmacies throughout the United States by mid-summer. Unimed Pharmaceuticals, Inc. is a wholly owned subsidiary Wholly Owned Subsidiary

A subsidiary whose parent company owns 100% of its common stock.

Notes:
In other words, the parent company owns the company outright and there are no minority owners.
 of Solvay Pharmaceuticals, Inc.

"We believe that doctors and men who are waiting for a more convenient testosterone treatment will regard AndroGel(TM) as a very attractive alternative to existing testosterone replacement therapy testosterone replacement therapy Androgen replacement therapy, see there ," said Robert E. Dudley, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , Unimed Pharmaceuticals, Inc. "AndroGel(TM) provides an easy, effective, invisible alternative to painful deep muscle injections and potentially irritating patches."

AndroGel(TM) is a unique, clear, colorless topical gel that men apply once daily to the shoulders, upper arms and/or abdomen. Upon application, AndroGel(TM) dries within a few minutes, during which time the skin absorbs the testosterone. The skin serves as a reservoir for the hormone, which slowly enters the bloodstream. Normal testosterone levels are restored soon after application. AndroGel(TM) is the only FDA approved testosterone replacement therapy available in gel form. AndroGel(TM) provides men with a safe, effective and easy-to-use treatment that can be applied at home.

Clinical data from a U.S. phase III study conducted in men with hypogonadism indicated that AndroGel(TM) quickly raised circulating testosterone to desirable levels, and maintained it within normal range. The study also found that AndroGel(TM) increased sex drive, bone mineral density bone mineral density
n.
See bone density.


bone mineral density A measurement of bone mass, expressed as the amount of mineral–in grams divided by the area scanned in cm2. See Bone densitometry.
, and lean body mass and improved mood and energy levels.

"Research supporting the use of AndroGel(TM) is extremely solid and the unique gel delivery method is very versatile," said Ronald S. Swerdloff, M.D., chief and professor of Medicine, Division of Endocrinology at Harbor-UCLA Medical Center Harbor-UCLA Medical Center is a hospital located within the city of Torrance, California, USA. The hospital was founded in 1946, and is funded by Los Angeles County

Harbor-UCLA serves as the Level I Trauma Center for the South Bay area.
. "Testosterone deficient men who use AndroGel(TM) can experience physical and psychological benefits with this convenient, well-tolerated gel."

Safety data from clinical studies of AndroGel(TM) demonstrate it to be well tolerated. Androgens Androgens
Male sex hormones produced by the adrenal glands and testes, the male sex glands.

Mentioned in: Acne, Congenital Adrenal Hyperplasia, Finasteride, Homocysteine, Polycystic Ovary Syndrome, Salpingo-Oophorectomy

 are contraindicated in men with carcinoma of the breast, or known or suspected carcinoma of the prostate. Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma. AndroGel(TM) is not indicated for use in women and has not been evaluated in women. Pregnant women should avoid skin contact with AndroGel(TM) application sites in men. Testosterone may cause fetal harm.

Studies have shown that during vigorous skin to skin contact some of the testosterone in AndroGel(TM) can be transferred to the untreated individual. Residual testosterone on the skin can be removed with soap and water. Testosterone should not be used to improve athletic performance.

For full prescribing information, physicians and patients may visit www.Unimed.com or call 877-463-7645.

Unimed Pharmaceuticals, Inc., a wholly owned subsidiary of Solvay Pharmaceuticals, Inc., focuses on drugs with multiple indications in the therapeutic areas of hypertension, endocrinology, urology, HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States.  and other infectious diseases.

Unimed currently markets Teveten(R) (eprosartan mesylate ep·ro·sar·tan mesylate
n.
An angiotensin II receptor antagonist used to treat hypertension.


eprosartan mesylate

Teveten

Pharmacologic class: Angiotensin II receptor antagonist

) for the treatment of hypertension, Marinol (dronabinol) as an appetite stimulant for people living with HIV disease and as an antiemetic for people with cancer, Anadrol(R)-50 (oxymetholone) for the treatment of various anemias, and Maxaquin(R) (lomefloxacin HCl), a broad-spectrum quinolone antibiotic, for both complicated and uncomplicated urinary tract infections.

Solvay Pharmaceuticals, Inc. of Marietta, Georgia, is a research-based pharmaceuticals company, active in the therapeutic areas of cardiology, gastroenterology, mental health and women's health Women's Health Definition

Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues.
. It is a member of the worldwide Solvay Group of chemical and pharmaceutical companies, headquartered in Brussels, Belgium.

For more information, call 312-240-2841.
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Comment:FDA APPROVES ANDROGEL TO TREAT MALE TESTOSTERONE DEFICIENCY.
Publication:Worldwide Biotech
Geographic Code:1USA
Date:Apr 1, 2000
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