FDA Sets Prescription Drug User Fee Act (PDUFA) Goal Date of August 26, 2020
ATHLONE, Ireland, March 26, 2020 /PRNewswire/ -- Innocoll Holdings Limited, a specialty pharmaceutical company and portfolio business of Gurnet Point Capital, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) resubmission for XARACOLL® (bupivacaine hydrochloride collagen-matrix implants), an investigational agent for the management of postsurgical pain after open inguinal hernia surgery. The FDA set a PDUFA goal date of August 26, 2020.
"The FDA acceptance of the NDA for XARACOLL brings us a step closer to providing a new and innovative non-opioid solution to surgeons and patients looking to manage postsurgical pain," said Rich Fante, CEO of Innocoll. "If approved, XARACOLL will be our first commercially available product in the US and we look forward to bringing this novel alternative to the market later this year."
XARACOLL is a late-stage bioresorbable collagen-matrix surgical implant being developed by Innocoll for the management of postsurgical pain relief through the delivery of bupivacaine, a local anesthetic, at the surgical site. XARACOLL is a registered trademark of Innocoll Pharmaceuticals Limited.
About Innocoll Holdings Limited
Innocoll Holdings Limited is a global specialty pharmaceutical company headquartered in Athlone, Ireland. Innocoll Holdings Limited and its subsidiary, Innocoll Pharmaceuticals Limited, are focused on the development and commercialization of pharmaceutical technologies to meet some of today's most important healthcare challenges. Innocoll Holdings Limited is a portfolio business of Gurnet Point Capital. www.innocoll.com
About Gurnet Point Capital
Gurnet Point Capital is a unique healthcare fund founded by Ernesto Bertarelli and led by Christopher Viehbacher, who, together, have decades of expertise in an industry for which they share a passion, both as Chief Executives and as investors. With an initial allocation of $2 billion, GPC is investing long-term capital and supporting entrepreneurs in building a new generation of companies. Based in Cambridge, MA, its remit is global, encompassing life sciences and medical technologies. The fund invests across all stages of product development through to commercialization and does so with an approach that is a hybrid of venture and private equity investing strategies.
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SOURCE Innocoll Holdings Limited