Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) obtained on Monday US Food and Drug Administration (FDA) marketing approval for its Abbreviated New Drug Application (ANDA) for Fentanyl Transdermal System and begun shipments.
Teva's version is a generic version of chronic pain treatment Duragesic, made by Ortho-McNeil-Janssen Pharmaceuticals Inc. The Duragesic patch is based on fentanyl.
According to IMS, brand and generic sales of Duragesic in the US totaled $1.2 billion in the 12 months through June.
Teva's Fentanyl patch system was developed and is manufactured by Florida-based Aveva Drug Delivery Systems Ltd., a unit of transdermal patch technology pioneer Nitto Denko Corporation (TSE: 6988) of Japan.
Fentanyl is used for management of persistent moderate to severe chronic pain that requires continuous opioid administration over an extended period of time and which cannot be managed by other means, such as non-steroidal analgesics, opioid combination products, or immediate-release opioids.
Teva fell 0.7% on Nasdaq yesterday to $41.05. The share rose 4.8% in morning trading on the TASE today.
Published by Globes [online], Israel business news - www.globes-online.com - on October 22, 2008
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