Drug Substitution Questions: Januvia®, Zituvio® and sitagliptin

an Authorized Generic of Zituvio^® and may be substituted at the pharmacy level without prescriber approval. Please note that pharmacies may not substitute sitagliptin for Januvia^®, nor can they substitute Zituvio^® for Januvia^® unless the prescriber approves, and this is documented with a clinical note.

Here is an excerpt from the FDA website explaining Authorized Generics:

“An authorized generic drug is the same as the brand-name drug but does not use the brand name on the label. In addition, an authorized generic version of a tablet or capsule may have a different color or marking. Because an authorized generic drug is marketed under the brand name drug’s New Drug Application (NDA), it is not listed in FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book). An authorized generic is considered to be therapeutically equivalent to its brand-name drug because it is the same drug.”

Here is a comparison table to help pharmacies understand the differences, note the matching FDA application numbers of Zituvio^® and sitagliptin.

NDCs with “xx” have multiple pack sizes

PAAS Tips:

• Authorized generics are NOT separately listed in FDA Orange Book
• If you are ever in doubt about product substitution, call the PAAS team for assistance