According to Alexza Pharmaceuticals, the company has submitted responses to the Day 120 List of Questions it received from the EMA’s Committee for Medicinal Products for Human Use in March 2012 regarding its marketing application for Adasuve inhaled loxapine. The company says that it expects to receive a Day 180 List of Outstanding Issues for the MAA by the end of September 2012.
Alexza also says that the EMA has accepted its corrective action plan for findings and recommendations that stemmed from the pre-approval inspection of its Mountain View, California manufacturing facility and that it expects to receive a EU Good Manufacturing Practices (GMP) Certificate.
The company is partnered with Grupo Ferrer to commercialize Adasuve in Europe, Latin America, Russia and the Commonwealth of Independent States countries.
In June 2012, Alexza resubmitted its NDA for Adasuve to the FDA after having received a Complete Response Letter the previous month.
Read the Alexza press release.
