Zdrowie i gospodarka · 21/11/1994

Abbreviated New Drug Application Regulations; Patent and Exclusivity Provisions

The AbbVie Inc. has submitted a request to the U.S. Food and Drug Administration (FDA) for approval of its abbreviated new drug application (ANDA) for the generic version of its multiple sclerosis treatment, Aubagio. The ANDA is part of a larger proposal to expand the availability of Aubagio to more patients.