$$$ Mylan Receives FDA Approval for Levothyroxine Sodium Tablets $$$ - 500 Beiträge pro Seite

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Mylan Lab. - MYL (NYSE) - 868270

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Press Release Source: Mylan Laboratories Inc.

Mylan Receives FDA Approval for Levothyroxine Sodium Tablets
Thursday June 24, 6:30 am ET


PITTSBURGH, June 24 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE: MYL - News) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval for Mylan Pharmaceuticals Inc.`s Abbreviated New Drug Application for Levothyroxine Sodium Tablets in 0.025 mg, 0.050 mg, 0.075 mg, 0.088 mg, 0.1 mg, 0.112 mg, 0.125 mg, 0.15 mg, 0.175 mg, 0.2 mg and 0.3 mg strengths.
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Levothyroxine Sodium Tablets are the generic version of Abbott Laboratories` Synthroid® Tablets.

"We are very pleased with this product approval," stated Robert J. Coury, Mylan`s Vice Chairman and CEO. "This approval represents a very important addition to our product portfolio and finally brings closure to some of the tactics used by others to delay legitimate generic approvals."

The product will be shipped immediately.

...

For more information about Mylan, visit www.mylan.com.

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Reuters
Abbott shares could fall on generic approval
Thursday June 24, 8:22 am ET


NEW YORK, June 24 (Reuters) - Shares of Abbott Laboratories Inc. (NYSE:ABT - News) could fall on Thursday after U.S. regulators approved generic rivals to its thyroid hormone replacement drug Synthroid earlier than expected, analysts said.
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On Wednesday the U.S. Food and Drug Administration denied an Abbott petition to block generic rivals. Sandoz Inc., a unit of Novartis AG (NOVN.VX) and Mylan Laboratories Inc. (NYSE:MYL - News) said they plan to start shipping their versions of the product immediately.

Synthroid is the second-most prescribed drug in the United States, but it is already relatively cheap, generating about $610 million a year.

Abbott stood by its forecast that it will make $2.24 to $2.31 a share, excluding one-time items, in 2004, but some analysts said the fact that the FDA`s approval of generics came earlier than expected could hurt the company`s stock.

"While the economic impact from the accelerated approval is not in our view meaningful, the event in itself could be enough to change the way the bullish camp on the Street has been viewing this stock," said Michael Weinstein, an analyst at JP Morgan, who has an "underweight" rating on Abbott`s stock.

King Pharmaceuticals Inc. (NYSE:KG - News) and Watson Pharmaceuticals Inc. (NYSE:WPI - News) also sell thyroid hormone replacement treatments, but they are not considered generic versions of Synthroid. On Thursday Lannett Company Inc. (AMEX:LCI - News) said it has received approval for a generic version of King`s Levoxyl. Novartis said its drug is also equivalent to Levoxyl.