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Glaxo HIV drug gets label update

GlaxoSmithKline said Friday it has recieved approval for updated labeling for its HIV protease inhibitor Lexiva.
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Published: Nov. 18, 2005 at 10:56 AM

WASHINGTON, Nov. 18 (UPI) -- GlaxoSmithKline said Friday it has received approval for updated labeling for its HIV protease inhibitor Lexiva.

Glaxo and its partner Vertex Pharmaceuticals said the Food and Drug Administration has approved GSK's application to add to Lexiva's prescribing data that simultaneous administration of the HIV treatment in combination with esomeprazole, sold as Nexium, does not result in lowering of blood levels of Lexiva.

The company said the new information is based on a study showing that blood levels of Lexiva remained unchanged when patients took the Glaxo drug concurrently with 20 milligram once-daily esomeprazole.

Drug interactions that result in lower PI blood levels may increase the risk for virologic failure in patients treated with HIV protease inhibitors, GSK said.

Topics: Food and Drug Administration
© 2005 United Press International, Inc. All Rights Reserved. Any reproduction, republication, redistribution and/or modification of any UPI content is expressly prohibited without UPI's prior written consent.

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