FDA approves revised prescribing info for Teva's Azilect

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) said that the US Food and Drug Administration (FDA) has reduced recommended medication and food restrictions for patients taking Parkinson's Disease drug Azilect.

Teva Neuroscience VP and US General Manager Jon Congleton said Teva welcomed the move as it "removes a barrier for some physicians, and some patients, living with Parkinson�s disease.�

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The FDA approved newly revised prescribing information for AZILECT, reducing medication and food restrictions. The revised update reflected reduced concerns regarding the use of AZILECT together with certain medications, including many over-the-counter cough/cold medications. In addition, patients taking AZILECT no longer need to follow a general dietary restriction of ordinary levels of tyramine, an amino acid found in certain foods and beverages, such as air-dried and fermented meats, aged cheeses and most soybean products.

The update was based on data which confirmed the mechanism of action of AZILECT as a selective MAO-B (monoamine oxidase-B) inhibitor. Due to potential mild increased sensitivity in some patients, Teva recommended ingestion of very high levels of tyramine (over 150 mg) should be avoided by patients taking MAO inhibitors.

Shares in Teva closed yesterday at $53.49, giving a market cap of $47.12 billion.

Published by Globes [online], Israel business news - www.globes-online.com - on December 15, 2009