FDA Approves Trulance for Chronic Constipation
January 19, 2017 - The U.S. FDA approved Trulance™ (plecanatide), manufactured by Synergy Pharmaceuticals. Trulance is indicated to treat adults who have chronic constipation without an apparent cause, known as chronic idiopathic constipation (CIC). CIC is believed to affect as many as 33 million individuals in the United States and is characterized by infrequent (three or less per week), incomplete and/or difficult bowel movements. Trulance stimulates an enzyme, guanylate cyclase-C (GC-C) that activates secretion of fluids in the gastrointestinal (GI) tract. One result is softer GI contents, which move through the intestines easier and faster. Taken once a day, Trulance will be available as 3mg tablets that can be crushed to mix with soft foods for those who cannot swallow whole tablets. Its labeling includes a boxed warning that children who take it may become seriously dehydrated. Thus, it is not indicated for patients under the age of 18 years. Launch is planned for later in the first quarter of 2017.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.