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FDA approves Actonel for once-a-week use.(Brief Article)
2002 JUL 4 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration (FDA) has approved a new 35 mg once-a-week dosage strength for Actonel (risedronate sodium tablets) for the prevention and treatment of postmenopausal osteoporosis. It will be available in mid-June 2002, by prescription only.
Robert Lindsay, MD, PhD, chief of internal medicine at Helen Hayes Hospital, Professor of Clinical Medicine, Columbia University, and principal investigator of the Actonel once-a-week approval study, stated that patients and doctors always welcome effective new treatment choices, and now there is data showing that once-a-week dosing of Actonel is therapeutically equivalent to daily 5 mg dosing.
The FDA based its approval on safety and efficacy data from a one-year, double-blind, multicenter study that included 1456 postmenopausal women with osteoporosis and compared the effects of the once-a-week and daily dosing of Actonel on bone mineral density (BMD). Patients taking Actonel 35 mg once-a-week experienced a ...
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- Press release article from: PR Newswire November 12, 2001 700+ words
...A once-a-week dosage of Actonel(R) (risedronate sodium...mg was as effective as daily Actonel 5 mg at increasing bone mineral...the study, patients taking Actonel 35 mg once a week experienced...increase achieved with the 5 mg daily dose. Total hip, femoral...
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...women. One group received Actonel 5 mg daily for 7 years; the other received...years and was then switched to Actonel 5 mg daily for 2 years. For those women...women: 83 patients received Actonel 5 mg daily for 7 years; 81 patients received...
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- Press release article from: PR Newswire September 20, 2002 700+ words
...to receive either placebo or Actonel 5 mg daily. All patients received 1 g...Actonel 35 mg Once-a-Week and Actonel 5 mg daily are indicated for the prevention...osteoporosis in postmenopausal women. Actonel 5 mg daily is also indicated for the prevention...
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- Press release article from: PR Newswire October 1, 2003 700+ words
...Actonel 35 mg Once-a-Week and Actonel 5 mg daily are indicated for the prevention...osteoporosis in postmenopausal women. Actonel 5 mg daily also is indicated for the prevention...incidence of adverse events with Actonel 5 mg daily was comparable to ...
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- Press release article from: PR Newswire February 10, 2003 700+ words
...women treated with placebo or Actonel 5 mg daily. All women received 1000 mg...Actonel 35 mg Once-a-Week and Actonel 5 mg daily are indicated for the prevention...osteoporosis in postmenopausal women. Actonel 5 mg daily is also indicated for the ...
- Actonel significantly reduced fractures in high-risk women.
- Newspaper article from: Health & Medicine Week March 10, 2003 700+ words
...women treated with placebo or Actonel 5 mg daily. All women received 1000 mg...Actonel 35 mg Once-a-Week and Actonel 5 mg daily are indicated for the prevention...osteoporosis in postmenopausal women. Actonel 5 mg daily is also indicated for the ...
- The U.S. Food and Drug Administration Approves Actonel for Broader Use in Men...
- Press release article from: PR Newswire August 14, 2006 700+ words
...risedronate sodium tablets) Actonel 5 mg daily and 35 mg once a week are indicated...in men with osteoporosis. Actonel 5 mg daily is indicated for the prevention...incidence of adverse events with Actonel 5 mg daily was comparable to placebo...
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- Press release article from: PR Newswire October 6, 2004 700+ words
...Aventis, part of the sanofi-aventis Group. Actonel 35 mg Once-a-Week and Actonel 5 mg daily are indicated for the prevention and treatment of osteoporosis in postmenopausal women. Actonel 5 mg daily is also indicated for the prevention and...