Heron Therapeutics: MAA for HTX-011 validated by European Medicines Agency
Heron Therapeutics announced that the Marketing Authorisation Application for its investigational agent, HTX-011, for postoperative pain, was validated by the European Medicines Agency. Validation of the MAA confirms that the submission is complete and starts the EMA's Centralised Procedure. The EMA granted eligibility to the Centralised Procedure for HTX-011 based on it meeting the criteria of a medicinal product constituting a significant scientific innovation. The Centralised Procedure allows applicants to receive a marketing authorisation that is valid throughout the European Union. With the validation of the MAA, an opinion from the EMA Committee for Medicinal Products for Human Use would be anticipated in the first half of 2020.