FDA approves Linzess as first oral treatment for pediatric functional constipation - Healio

[Health Reporter]

FDA approves Linzess as first oral treatment for pediatric functional constipation - Healio

 

The FDA has approved Linzess, the first therapy for pediatric functional constipation in patients aged 6 to 17 years, according to an agency release.

The supplemental new drug application for Linzess (linaclotide 72 µcg, AbbVie/Ironwood), which was previously approved for the treatment of adults with irritable bowel syndrome with constipation or chronic idiopathic constipation, was assigned an early Prescription Drug User Fee Act date of June 14, approximately 4 months earlier than would be assigned in the standard review cycle.

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