Posted by Michael Wonder on 20 Feb 2020
Heron Therapeutics announces FDA extension of review period for NDA for HTX-011 for the management of post-operative pain
19 February 2020 - Updated Prescription Drug User Fee Act goal date is 26 June 2020.
Heron Therapeutics today announced that the U.S. FDA has extended the review period for the new drug application for HTX-011 by up to three months.
A complete response letter was received from the FDA regarding the NDA for HTX-011 on April 30, 2019 relating to chemistry, manufacturing and controls and non-clinical information. Heron is pleased to report that the contract manufacturing site used to manufacture HTX-011 has been reinspected by the FDA with no Form 483 observations issued and with a recommendation by the FDA inspector for approval of the site. Heron has not been informed of any other manufacturing concerns. There were no clinical efficacy or safety issues in the CRL.
