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Classified in: Health
Subject: FDA

Norgine Announces FDA Filing Acceptance for PLENVU® (NER1006)



AMSTERDAM, June 28, 2017 /PRNewswire/ --

Launch date set for first quarter 2018 

Norgine B.V. today announced that it has received acceptance from the US Food and Drug Administration (FDA) for the New Drug Application (NDA) for PLENVU®* (NER1006). PLENVU® is a novel, low-volume (1L) polyethylene glycol based bowel preparation that has been developed to provide complete bowel cleansing, with an additional focus on the ascending colon.

In August 2016, Norgine out-licensed PLENVU® to Salix in the US and Canada.

Peter Stein, Chief Executive Officer, Norgine, said "We are pleased to receive filing acceptance from the FDA for PLENVU® and we are looking forward to continuing our collaboration with Salix. This partnership will ensure that patients have access to a new and proven low volume bowel preparation that can improve the quality of colonoscopy. In turn this will ultimately enhance the detection of adenomas and polyps that frequently go undetected and often result in colorectal cancer."

"Effective bowel preparation is an important factor for a successful colonoscopy and for detecting adenomas and polyps," said  Mark McKenna, senior vice president and general manager, Salix Pharmaceuticals.  "If approved, PLENVU® may enhance bowel cleansing and the overall bowel prep experience relating to a colonoscopy."

Norgine will manufacture PLENVU® globally and commercialise the product through its infrastructure in Europe, Australia and New Zealand.

*Provisionally approved name

View the full release on http://www.norgine.com

Norgine Media Contacts
Isabelle Jouin,
T: +44 (0)1895 453643

Charlotte Andrews,
T: +44 (0)1895 453607
Follow us @norgine


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News published on 28 june 2017 at 16:00 and distributed by: