Cytori Files Pre-submission Request for New Drug Application
CYTORI THERAPEUTICS (CYTX)
Last cytori therapeutics earnings: 11/14 04:15 pm
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Source: GlobeNewswire
SAN DIEGO, March 07, 2019 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ: CYTX) today announced that it officially filed a formal new drug application pre-submission request to the European Medicine Agency (EMA) for Doxorubicin Hydrochloride Cytori. This submission is the precursor to filing an Article 58 Application for a Marketing Authorization Application (MAA) via EMA’s centralized approval procedure. In June 2017, the EMA Committee for Medicinal Products for Human Use (CHMP) confirmed that Doxorubicin Hydrochloride Cytori was eligible for submission of a MAA via the centralized procedure. In addition, in late 2018, the EMA CHMP Name Review Group validated Doxorubicin Hydrochloride Cytori as the official invented name to replace ATI-0918. Doxorubicin Hydrochloride Cytori is a liposomal nanoparticle medicinal product being developed for cancer patients that contains the active substance doxorubicin, a widely used chemotherapy drug. Doxorubicin Hydrochloride Cytori is
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