The drug, Replagal, is an enzyme replacement therapy for the disease, which causes fat to build up in the body.
Shire had filed in November for FDA approval for Replagal, in anticipation of a quick review process, the company said.
Shire said the FDA did not express concerns over Replagal's safety. But recent interactions with the FDA have led the company to believe that the agency will require additional controlled trials for approval, Shire said.
The company said the likely additional studies would cause a significant delay, and an approval of Replagal for U.S. patients would only be possible in the distant future.
Shire was permitted to supply the drug to the U.S. market after manufacturing problems in 2009 led to short supplies of Fabrazyme, which is made by Genzyme, now owned by Sanofi SA
Sanofi said earlier this month that it had begun U.S. deliveries of Fabrazyme from its newly approved manufacturing plant in Framingham, Massachusetts. The French company said a full return to normal supply levels would begin in the second quarter and continue throughout 2012.
(Reporting By Deena Beasley in Los Angeles; editing by Matthew Lewis and Carol Bishopric)