Posted by Michael Wonder on 18 Jul 2019
Horizon Therapeutics announces U.S. FDA acceptance of its new drug application to make Procysbi (cysteamine bitartrate) available as oral granules in packets
18 July 2019 - Horizon Therapeutics announced today that the U.S.FDA has accepted Horizon’s new drug application for Procysbi (cysteamine bitartrate) delayed release oral granules in packets.
If approved by the FDA, this new dosage form would provide another option for patients, in addition to the currently available Procysbi delayed release capsules. The capsules are FDA-approved for children one year of age and older and adults living with nephropathic cystinosis.
The FDA is expected to make a decision on the approval of the proposed new dosage form of granules in packets in 2020.
