Posted by Michael Wonder on 19 Dec 2019
Averitas Pharma announces FDA acceptance of sNDA filing for Qutenza (capsaicin) 8% patch for the treatment of neuropathic pain associated with diabetic peripheral neuropathy
18 December 2019 - PDUFA date set for 19 July 2020.
Averitas Pharma announced today that the supplemental new drug application for Qutenza for the treatment of neuropathic pain associated with diabetic peripheral neuropathy has been accepted for review by the U.S. FDA.
"This is a great step forward for Averitas and moves us closer towards our goal of getting Qutenza FDA approved for this indication," says Gabriel Baertschi, CEO Grünenthal. "There are millions of patients with painful diabetic peripheral neuropathy who have so far struggled to find effective pain relief. Offering solutions for these patients' unmet needs is fully in line with our vision of working towards a world free of pain."
