TRULANCE

批准信原文要点

This Changes Being Effected supplemental new drug application provides for updates to the Prescribing Information to section 6.2 Postmarketing Experience to include hypersensitivity reaction and vomiting.

批准信原文要点

This “Changes Being Effected” supplemental new drug application provides criteria used in reporting of diarrhea as an adverse reaction in patients with chronic idiopathic constipation (CIC) through the addition of a footnote to Table 1 in the Adverse Reactions section of the label.

批准信原文要点

This Prior Approval supplemental new drug application provides for updates to the Prescribing Information in subsection 8.2 Lactation in the Use in Specific Populations section to include results of a milk-only lactation study (PMR 3117-14).

批准信原文要点

This “Changes Being Effected” supplemental new drug application proposes to modify the approved label for clarity and consistency as follows: • Table 4 - Study 3, in the Treatment Difference column an end parenthesis was changed to an end bracket for consistency. • In Table 4, for Study 3 change to the placebo N to 350 and change to the TRULANCE N to 349.

批准信原文要点

This Prior Approval supplemental new drug application proposes a new indication for irritable bowel syndrome with constipation (IBS-C).