FDA PANEL states no need for blackbox warning

Posted by jrbecker on October 26, 2005, at 14:06:39

http://today.reuters.com/investing/financeArticle.aspx?type=governmentFilingsNews&storyID=URI:urn:newsml:reuters.com:20051026:MTFH12272_2005-10-26_18-00-29_N26349399:1
UPDATE 1-Data shows low-dose Emsam is safe - US FDA panel
Wed Oct 26, 2005 2:00 PM ET
GAITHERSBURG, Md., Oct 26 (Reuters) - A low-dose version of Somerset Pharmaceuticals Inc.'s proposed Emsam depression patch can be safely used without a label warning against eating certain foods, a U.S. panel of health experts said on Wednesday.
Somerset, a joint venture of Mylan Laboratories Inc. <MYL.N> and Watson Pharmaceuticals Inc. <WPI.N>, is awaiting final U.S. Food and Drug Administration approval for the drug and is seeking to avoid a dietary warning for its lowest proposed dose of 20 milligrams.
Bristol-Myers Squibb <BMY.N> holds U.S. and Canadian marketing rights for Emsam.
The panel voted 7-4 that the low-dose version of Emsam could be used safely without the warning.
Mylan shares were up nearly 3 percent in afternoon trading, while Watson and Bristol-Myers shares were fractionally higher.
If approved, Emsam would be the first skin patch to treat depression on the market. It received conditional approval last year, and a final decision is expected in late November. The agency usually follows its advisers' advice.
Emsam is a monoamine oxidase inhibitor, or MAOI, a type of antidepressant that already carries strong warnings about the risk of high blood pressure when patients take it and eat smoked meats, dairy products and other foods containing the compound tyramine.
Somerset officials told panelists that because it is delivered through the skin and is not ingested, Emsam is safer. Their data showed its lowest proposed dose of 20 milligrams did not need the warning, but there was not enough data to consider waiving a warning for 30- or 40-milligram versions, they said.
In a second vote, the panelists narrowly decided that it would not be too confusing to have a warning on high-dose versions but not the low dose one. One panelist left the meeting early, making the second vote 6-4.
Shares of Mylan were up 60 cents at $21.59, Watson shares rose 8 cents at $35.73, and Bristol-Myers Squibb shares were up 11 cents at $21.76. All three stocks trade on the New York Stock Exchange.

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FDA reviewer recommends blackbox warning for EMSAM jrbecker 10/25/05
Re: FDA reviewer recommends ....update 1 jrbecker 10/25/05
Re: FDA reviewer recommends ....update 1 med_empowered 10/25/05
Re: FDA reviewer recommends blackbox warning for EMSAM ed_uk 10/25/05
Re: FDA reviewer recommends blackbox warning for EMSAM cecilia 10/26/05
FDA PANEL states no need for blackbox warning jrbecker 10/26/05
FDA PANEL states no need for blackbox warning jrbecker 10/26/05
Re: FDA PANEL states no need for blackbox warning RobertDavid 10/26/05
Re: FDA PANEL states no need for blackbox warning Cecilia 10/27/05
Re: thanks jrbecker! (nm) ravenstorm 10/27/05
Re: FDA reviewer recommends blackbox warning for E Psyc 1 10/27/05
Re: FDA PANEL states no need for blackbox warning jclint 10/27/05

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