The Global Registration of Zyprexa™ (Olanzapine)

Autor: Robert E. Hizer, Susanne Acklin, Jeffrey T. Ramsey, John C. Saunders, Sue T. Worthen, Diana L. Mckenzie, Jeffrey S. Kasher
Rok vydání: 1997
Předmět:
Zdroj: Drug Information Journal. 31:49-55
ISSN: 2164-9200
0092-8615
DOI: 10.1177/009286159703100108
Popis: The 1995 global registration submissions of olanzapine, a novel agent for the treatment of schizophrenia and related psychosis, represented an historical achievement for the Lilly development and regulatory organizations. Lilly achieved registration submissions in 21 countries within days of one another. After over a century of historically United States-focused pharmaceutical operations, this task was unprecedented. This goal was supported by an overall strategic plan which was communicated and implemented worldwide. Positive partnerships with regulators, effective application of state-of-the-art information technologies, and teamwork were central to the success of this effort.
Databáze: OpenAIRE