SB2000Under the US Orphan Drug Act, uponmarketing authorization...

SB2000

Under the US Orphan Drug Act, upon
marketing authorization and during the period of market exclusivity, the FDA does not accept or
approve other applications to market the same medicinal product for the same therapeutic
indication. In addition to potential market exclusivity, orphan drug status provides up to 50% in
U.S. tax credits, grant funding for research and development and reduced filing fees, expedited
review as well as advice on the conduct of clinical trials.

It's an important step in expediting a drug's entry into the US market.