NLS Obtains License to Full Regulatory Data Package and know-how
NLS Pharmaceutics Obtains License to Full Regulatory Data Package and Proprietary Know-How for Sanorex® (Mazindol)
Agreement provides exclusive rights to all available data included in the original new drug application ("NDA") for mazindol in the U.S.
$NLSP announces that it has entered into a License Agreement (the "Agreement") with Novartis Pharma AG, whereby the Company has obtained, on an exclusive basis in the United States, all of the available data referred to and included in the original NDA for Sanorex® (mazindol) submitted to the United States Food and Drug Administration in February 1972.
The Agreement encompasses all preclinical and clinical studies, data used for manufacturing including stability and other chemistry manufacturing and controls data, formulation data and know-how for all products containing mazindol as an active substance, and all post-marketing clinical studies and periodic safety reports from 1973 forward.
Under the Agreement, NLS has obtained the same rights on an non-exclusive basis in all territories outside of the U.S, except for Japan, with the right to cross-reference the Sanorex NDA with non-U.S. regulatory agencies in the licensed territories.
finance.yahoo.com/ne...-full-130000368.html
Agreement provides exclusive rights to all available data included in the original new drug application ("NDA") for mazindol in the U.S.
$NLSP announces that it has entered into a License Agreement (the "Agreement") with Novartis Pharma AG, whereby the Company has obtained, on an exclusive basis in the United States, all of the available data referred to and included in the original NDA for Sanorex® (mazindol) submitted to the United States Food and Drug Administration in February 1972.
The Agreement encompasses all preclinical and clinical studies, data used for manufacturing including stability and other chemistry manufacturing and controls data, formulation data and know-how for all products containing mazindol as an active substance, and all post-marketing clinical studies and periodic safety reports from 1973 forward.
Under the Agreement, NLS has obtained the same rights on an non-exclusive basis in all territories outside of the U.S, except for Japan, with the right to cross-reference the Sanorex NDA with non-U.S. regulatory agencies in the licensed territories.
finance.yahoo.com/ne...-full-130000368.html