Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has suspended sales of migraine treatment patch ZECUITY (sumatriptan iontophoretic transdermal system) in the US. The Israeli pharmaceutical company has received post-marketing reports of application site reactions described as burns and scars in patients treated with ZECUITY, and said it is working in full cooperation with the US Food and Drug Administration (FDA) to better understand these adverse events. Teva has also initiated a pharmacy-level recall of the product.
Teva gained the ZECUITY patch as part of its $163 million acquisition of Nupathe in 2014. ZECUITY is considered an ethical Teva drug but is not an important part of its branded portfolio in terms of sales.
“At Teva, the wellbeing of people using our products is always the first priority. Given our deep commitment to patient safety, we will engage in a voluntary suspension of marketing while we continue our investigation into the root cause of these adverse skin reactions,” said Rob Koremans, president and CEO of Global Specialty Medicines at Teva. “We will continue to work closely with the FDA to resolve any remaining questions.”
Teva said that patients are advised to discontinue the use of ZECUITY and discuss alternative treatment options with their physicians.
Published by Globes [online], Israel business news - www.globes-online.com - on June 13, 2016
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