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FDA revises finding on estrogen/androgen combination products.
2003 MAY 8 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration (FDA) is beginning a formal administrative process to examine the effectiveness of estrogen/androgen combination products for the treatment of hot flashes associated with menopause.
FDA is acting because it does not believe there is substantial evidence that androgens contribute to the effectiveness of these combination products to treat hot flashes in menopausal women who do not find relief from these symptoms when using estrogens alone. Estrogen/androgen combination products were found effective for this indication under a determination FDA made in a 1976 Federal Register notice.
FDA is also offering affected parties the opportunity for a hearing on this issue.
FDA is aware of at least two currently marketed products affected by this proceeding: Estratest and Estratest H.S. Neither of these products has been approved.
It has been FDA's long-standing policy to allow the continued marketing of drug products while matters such as these are being resolved, provided there is no documented serious public health or ...
- ESTROGEN/ANDROGEN COMBINATION (Oral route, Parenteral route).(Drug overview)
- USP DI-Volume II, Advice for the Patient: Drug Information in Lay Language May 1, 2007 700+ words
Brand names in the United States -- * Essian Dosage forms -- * Tablet DESCRIPTION OF USE Androgens and estrogens are hormones. Estrogens are produced by the body in greater amounts in females. They are necessary for normal sexual development of the female and for regulation of the menstrual cycle
- Estrogen and androgen combination urged.
- Magazine article from: Chain Drug Review August 31, 1998 700+ words
A panel of women's health experts recommends combining estrogen and androgen to treat various symptoms in postmenopausal patients. The group, affiliated with the University of Medicine and Dentistry of New Jersey, cites studies showing that when the two are given together, such symptoms as sexual
- FDA to scrutinize efficacy of Estratest for hot flashes: manufacturer to defend...
- Magazine article from: Family Practice News Johnson, Kate May 15, 2003 700+ words
...benefits of estrogen/androgen combination products require resolution if...may try the estrogen-androgen combination," he told FAMILY PRACTICE...pending. Estrogen/androgen combination products were first declared effective...
- Estrogen/androgen combo questioned for hot flashes: FDA; 'substantial evidence...
- Magazine article from: OB GYN News Johnson, Kate May 15, 2003 700+ words
...benefits of estrogen / androgen combination products require resolution if...may try the estrogen-androgen combination," he said in an interview...pending. Estrogen/androgen combination products were first declared effective...
- Combination products challenge their packaging.(PACKAGING WRAP-UP)(Interview)
- Magazine article from: Medical Design Dvorak, Paul July 1, 2008 700+ words
...developments, especially for combination products, we posed several questions...developing in the packaging of combination products? EH: The next generation of packaging for combination products will require greater flexibility...
- Senior Panel Outlines Strategies for Streamlining Regulation of Combination...
- Press release article from: PR Newswire January 14, 2005 700+ words
...journey increases exponentially. Combination products are a growing -- and relatively...consistent approach toward reviewing combination products. Drugs, medical devices and biologics...approaches toward reviewing the combination products that are submitted for FDA approval...
- Combination Products Are A Lifeline In Todays Pharmaceutical Industry, But Not...
- Press release article from: M2 Presswire June 8, 2007 700+ words
...June 2007-Research and Markets: Combination Products Are A Lifeline In Todays Pharmaceutical...REPORT: Getting Maximum Benefit from Combination Products" to their offering Combination products are a lifeline in today's pharmaceutical...
- FDA establishes Office of Combination Products. (Regulatory Update).
- Newspaper article from: Research Practitioner January 1, 2003 700+ words
...and device-biologic combination products that are becoming more...care. The new Office of Combination Products (OCP) will be part of...regulatory life cycle of combination products, including jurisdiction...
- Faster approvals seen for drug and device combination products.
- Newspaper article from: The BBI Newsletter Patterson, Nancy September 1, 2003 700+ words
Combination products--those products that contain...of clarity in post-market combination products regulatory controls created...for the exploding number of combination products being presented for review...
- Combination Products Are a Lifeline in Today's Pharmaceutical Industry, but Not...
- Press release article from: Business Wire June 8, 2007 700+ words
...REPORT: Getting Maximum Benefit from Combination Products" to their offering. Combination products are a lifeline in today's pharmaceutical...Therefore, not all potential combination products will have equal value. We asked...
Source: HighBeam Research, FDA revises finding on estrogen/androgen combination products.