Posted from: Monday, August 01, 2016 - 12:39 PM - Present

Relistor Oral Tablet Approval Announced

July 19, 2016 – The U.S. FDA approved Relistor® (methylnaltrexone) oral tablets, manufactured by Valeant Pharmaceuticals International. Relistor is indicated to treat opioid-induced constipation (OIC) for adult palliative-care patients who are in late stage illnesses and was only available only as a subcutaneous injection, until now. In addition to the new form, Relistor also has an additional approval to treat OIC for adults with chronic pain that is not caused by cancer.

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 regular mail or by fax.

Actual drug patent expiration dates and a 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 Thursday, March 23, 2017 - 09:34 AM.