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news.The US Food and Drug Administration (FDA) has approved ProStrakan Group's Rectiv (nitroglycerin) Ointment 0.4 % to treat moderate to severe pain linked with chronic anal fissures.
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A subsidiary of Japan-based global specialty pharmaceutical company Kyowa Hakko Kirin, ProStrakan aims to introduce Rectiv in the first quarter of 2012 in the US.
Marketed under the name Rectogesic, the product is already approved in the EU and marketed by ProStrakan in all major European countries.
ProStrakan chairman Peter Allen said the market in the US for a prescription medicine to treat chronic anal fissure pain is significant and, having successfully marketed this product in Europe for some years, they are pleased that it will now be made available to patients in the US.
"We will now evaluate the most efficient way of bringing this product to market and making it available as widely as is necessary," Allen said.