Posted from: Wednesday, February 01, 2017 - 05:58 PM - Present

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.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Tuesday, October 22, 2019 - 07:54 AM.