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Misleading ads.(POLICY & PRACTICE)

OB GYN News

| February 01, 2005 | Schneider, Mary Ellen | COPYRIGHT 2005 International Medical News Group. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

The Food and Drug Administration recently warned Barr Research that one of its advertisements for the oral contraceptive Seasonale (levonorgestrel/ethinyl estradiol) was misleading consumers. "By omitting and minimizing the risks associated with Seasonale, the TV ad misleadingly suggests that Seasonale is safer than has been demonstrated by substantial evidence or substantial clinical experience," the FDA said in a letter. The ad fails to mention that patients using Seasonale may experience breakthrough bleeding or spotting ...

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FDA Approves Barr's SEASONALE(R), An Extended-Cycle Oral Contraceptive First...: Press release article from: PR Newswire September 5, 2003 700+ words
...Drug Administration (FDA) has approved the Company's SEASONALE(R) (levonorgestrel...prevention of pregnancy. SEASONALE, the first and only FDA-approved extended...clinical data supporting FDA approval of the SEASONALE(R) (levonorgestrel...


FDA Approves Barr's SEASONALE(R), an Extended-Cycle Oral Contraceptive First...: Press release article from: PR Newswire September 5, 2003 700+ words
...Drug Administration (FDA) has approved the Company's SEASONALE(R) (levonorgestrel...prevention of pregnancy. SEASONALE, the first and only FDA-approved extended...clinical data supporting FDA approval of the SEASONALE(R) (levonorgestrel...


Watson Pharma gets FDA OK for generic Seasonale.: News wire article from: The America's Intelligence Wire September 7, 2006 700+ words
...data from IMS Health. Seasonale is made by Barr's Duramed...the heels of Waston's FDA approval, which came after Seasonale's three-year product...seek a reissue of the Seasonale patent. Although the FDA is barred from approving...


UPDATE 1-Watson Pharma gets FDA OK for generic Seasonale.: News wire article from: The America's Intelligence Wire September 7, 2006 700+ words
...data from IMS Health. Seasonale is made by Barr's Duramed...the heels of Waston's FDA approval, which came after Seasonale's three-year product...seek a reissue of the Seasonale patent. Although the FDA is barred from approving...


UPDATE 2-Watson Pharma gets FDA OK for generic Seasonale.: News wire article from: The America's Intelligence Wire September 7, 2006 700+ words
...data from IMS Health. Seasonale is made by Barr's Duramed...the heels of Waston's FDA approval, which came after Seasonale's three-year product...seek a reissue of the Seasonale patent. Although the FDA is barred from approving...


Multimedia Available: FDA Approves Barr's SEASONALE, an Extended-Cycle Oral...: Press release article from: Business Wire September 5, 2003 700+ words
...that the U.S. Food and Drug Administration (FDA) has approved the Company's SEASONALE(R) (levonorgestrel and ethinyl estradiol...prevention of pregnancy. SEASONALE, the first and only FDA-approved extended-cycle oral contraceptive...


Shares of Barr Labs rose 8.35 percent to close at $75.25 on Monday following...: News wire article from: Drug Store News - NewsFirst September 10, 2003 700+ words
...Shares of Barr Labs rose 8.35 percent to close at $75.25 on Monday following the FDA approval of its new oral contraceptive Seasonale, the first and only FDA-approved extended-cycle oral contraceptive that reduces women's periods from...


Press Release: Barr's Seasonale NDA accepted for filing by FDA.: News wire article from: Asia Africa Intelligence Wire September 17, 2002 700+ words
...the US Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) for its Seasonale extended regimen oral contraceptive...seeking approval to manufacture and market Seasonale extended regimen oral contraceptive for...


Watson gets FDA OK for Seasonale clone.: News wire article from: Europe Intelligence Wire September 7, 2006 700+ words
...version of Barr Pharmaceuticals Inc.'s Seasonale birth control pill. The agency approved...milligrams, the hormone combination used in Seasonale, made by Barr's Duramed Pharmaceuticals unit. Seasonale differs from other birth control pills...


Barr Laboratories.(Pipeline)(receives FDA approval for the Seasonale...: Magazine article from: Medical Marketing & Media October 1, 2003 700+ words
Barr Laboratories reported that the FDA has approved the Seasonale (levonorgestrel and ethinyl estradiol) 0.15mg...reduce the number of periods from 13 to 4 per year. Seasonale will be available late October.

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