Alexza Pharmaceuticals has received a EU Certificate of GMP Compliance of a Manufacturer subsequent to a May 2012 inspection by the Agencia Espanola de Medicamentos y Productos Sanitarios, the company has announced. Alexza plans to manufacture Adasuve Staccato loxapine at the facility in Mountain View, CA. Alexza says that the initial certificate will remain valid through May 15, 2015.
Alexza submitted responses to the Committee for Medicinal Products for Human Use (CHMP) Day 120 List of Questions in July 2012 and says that it expects to receive the Day 210 CHMP Opinion in December 2012. Alexza is partnered with Grupo Ferrer on the commercialization of Adasuve in Europe, Latin America, Russia, and the Commonwealth of Independent States countries
In the US, after receiving several complete response letters for Adasuve, Alexza resubmitted its NDA in June 2012, with a PDUFA goal date of December 21, 2012.
Read the Alexza press release.
