Tacrolimus capsules manufactured by Accord Healthcare Inc.
Based on new data, FDA has concerns about whether the tacrolimus oral capsule products manufactured by Accord Healthcare Inc., are therapeutically equivalent to the brand-name drug, Prograf (tacrolimus) oral capsules. These drugs are indicated for the prevention of organ rejection in adult patients receiving kidney, liver, or heart transplants, and in pediatric patients receiving liver transplants.
As a result, FDA has changed the therapeutic equivalence (TE) rating for Accord Healthcare Inc.’s tacrolimus oral capsules from AB to BX. This means that the data are insufficient to show that the product provides the same therapeutic effect and safety profile as Prograf (tacrolimus) oral capsules and are no longer recommended as automatically substitutable at the pharmacy for Prograf (tacrolimus) oral capsules.
Prograf (tacrolimus) oral capsules and generic tacrolimus oral capsules manufactured by companies other than Accord Healthcare Inc., are not affected by this issue. Other tacrolimus dosage forms are also not affected by this issue, including tacrolimus extended-release oral capsules, tacrolimus granules for oral suspension, tacrolimus injection products for intravenous use, and tacrolimus topical ointments.
Patients should determine the manufacturer of their tacrolimus oral capsules by contacting their pharmacy. Patients currently taking Accord Healthcare Inc.’s tacrolimus oral capsules should contact their prescribing healthcare professional to discuss switching to an alternative tacrolimus oral capsule. Patients should also inform their health care professional if they have experienced any problems that may be related to taking Accord Healthcare Inc.’s tacrolimus oral capsules. Patients should not make changes to their treatment except in consultation with their health care professional. Learn More: