Teva Pharmaceutical Industries receives approval for newly revised prescribing information for AZILECT

Dec 15 2009

Teva Pharmaceutical Industries, Ltd. (NASDAQ: TEVA) today announced the U.S. Food and Drug Administration (FDA) approved the newly revised prescribing information for AZILECT^® (rasagiline tablets) reducing medication and food restrictions. This update was based on clinical data that confirmed the mechanism of action of AZILECT^® as a selective MAO-B (monoamine oxidase-B) inhibitor at the recommended doses of 1 mg and 0.5 mg.

The newly approved prescribing information reflects 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. However, due to potential mild increased sensitivity in some patients, ingestion of very high levels of tyramine (e.g., >150 mg) should be avoided by patients taking MAO inhibitors.

"The FDA's decision to modify the AZILECT^® prescribing information emphasizes the benefit to patients of AZILECT^® MAO-B selectivity at recommended doses,” said Daniel Kremens, M.D., Assistant Professor of Neurology and Co-Director of the Parkinson’s Disease and Movement Disorders Division at Jefferson Medical College of Thomas Jefferson University in Philadelphia. “This is good news for patients and physicians as it reconfirms the safety and convenience of AZILECT^®.”

“We are pleased with this important change in the prescribing information of AZILECT® as it removes a barrier for some physicians, and some patients, living with Parkinson’s disease,” said Jon Congleton, VP and General Manager, U.S., Teva Neuroscience. “Physicians can now better focus on what is really most important, which is helping patients receive a proven efficacious and safe treatment, at diagnosis early in Parkinson’s disease, and throughout the course of the disease.”