In May of 2017, the FDA posted a notice about the Sucraid shortage because the product did not meet the Agency’s good manufacturing practices. A limited amount of unapproved product was made available in the meantime to patients who consented to its use. The Company stated that they are now able to meet all prescription demands for Sucraid without informed consent.
Sucraid is indicated as oral replacement therapy of the genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID). CSID is a chronic, autosomal recessive, inherited phenotypically heterogeneous disease with very variable enzyme activity. In the absence of endogenous human sucrase, as in CSID, sucrose is not metabolized. Sucraid helps to improve the breakdown and absorption of sucrose from the intestine which can help relieve the gastrointestinal symptoms of CSID.
“FDA approval will provide broad access to a doctor-prescribed therapy for adults and children to help manage the symptoms of CSID,” said Derick Cooper, CEO of QOL Medical, LLC.
For more information visit Sucraid.net.