The U.S. Food and Drug Administration today issued an expedited approval of a supplemental application that allows for changes in the manufacturing of Sucraid (sacrosidase) Oral Solution.
As part of the U.S. Food and Drug Administration's ongoing efforts to ensure that heparin for patients remains safe, the government today seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio.
Children born with a condition that can prevent them from growing to a normal height now have a new treatment option available with the approval of Norditropin(R) (somatropin [rDNA origin] injection) for the treatment of short stature in children born Small for Gestational Age with no catch-up growth by age 2-4 years.
The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling.