Posted from: Wednesday, June 29, 2016 - 11:18 AM - Present

Higher Strength for Orfadin Approved

June 15, 2016 – The U.S. Food and Drug Administration (FDA) approved Orfadin® (nitisinone) in a new 20mg capsule.  Orfadin, manufactured by Sobi, was initially approved in 2002 and is also available as 2mg, 5mg, and 10mg capsules, and as a 4mg/mL oral suspension.  It is indicated for the treatment of Hereditary Tyrosinaemia type-1 (HT-1), a rare and progressive disease that results in potentially fatal liver and kidney complications. 

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 Friday, October 11, 2019 - 02:30 PM.