Pharmaceutical company Innocoll Holdings Limited said on Thursday that it has re-filed its New Drug Application (NDA) with the US Food and Drug Administration (FDA) for XARACOLL.
The investigational agent XARACOLL (bupivacaine hydrochloride collagen-matrix implants) is being reviewed for the management of postsurgical pain after open inguinal hernia surgery.
The FDA has set a PDUFA goal date of 26 August 2020.
XARACOLL is a late-stage bioresorbable collagen-matrix surgical implant that is being developed by Innocoll for the management of postsurgical pain relief through the delivery of bupivacaine, a local anaesthetic, at the surgical site.
If approved by the FDA, XARACOLL will be Innocoll's first commercially available product in the United States.
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