Alexion Pharmaceuticals Inc. said Monday the Food and Drug Administration cleared the company's Rhode Island manufacturing facility for Soliris.
European regulators cleared the facility, located in Smithfield, earlier this year.
The drug is already on the market in the U.S., and treats a rare chronic disease called paroxysmal nocturnal hemoglobinuria, which causes a breakdown of red blood cells and leads to anemia.
Soliris is Alexion's only marketed product.
Alexion shares rose 95 cents to $56.60 morning trading.