Zydus Worldwide DMCC: sitagliptin

This NDA provides for the use of Sitagliptin Tablets as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

It is tentatively approved under 21 CFR 314.105 for use as recommended in the agreed-upon enclosed labeling (text for the Prescribing Information, Medication Guide, and carton and container labeling).

Agency at this time, [i.e., information in your application and the status of current good manufacturing practices (CGMPs) of the facilities used in the manufacture and testing of the drug product].

Therefore, final approval of your application under section 505(c)(3) of the Act [21 U.S.C. 355(c)(3)] may not be granted before the period has expired.

Therefore, final approval cannot be granted until:

To obtain final approval of this application, submit an amendment two or six months prior to the: (1) expiration of the patent(s) and exclusivity protection or (2) date you believe that your NDA will be eligible for final approval, as appropriate.

In addition to a safety update, the amendment should also identify changes, if any, in the conditions under which your product was entatively approved, i.e., updated labeling; chemistry, manufacturing, and controls data;

Until we issue a final approval letter, this NDA is not approved.

We note that if this application is ultimately approved, you will need to meet these requirements.