Azurity Pharmaceuticals, Inc.: sitagliptin

Drug, and Cosmetic Act for sitagliptin oral solution.

The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA 483 prior to your complete response.

As the applicant, we do not expect a response to this facility-related deficiency.

You may respond to deficiencies in this Complete Response Letter while the travel restrictions remain in effect.

However, even if these deficiencies are addressed, the application cannot be approved until the required FDA inspection is conducted and any findings are assessed with regard to your application.

Food, Drug, and Cosmetic Act for omeprazole and sodium bicarbonate for oral suspension.

January 8, 2021, which were not reviewed for this action.

(1) The strength of the active ingredient, sodium bicarbonate, in the drug product throughout the product shelf-life and during the in-use period is not adequately assured.

(2) The strength and uniformity of the active ingredient omeprazole in the constituted suspension at release and on stability are not assured.

MET-CDM-000025 for omeprazole identification, assay, and within bottle uniformity, submitted on October 16, 2020 (SN 0027), differs from the assay procedure (4) submitted in SN 0001)) used for analyzing the constituted suspension in the registration stability studies.

The drug product batches should be packaged in the to-be-marketed container closure systems and manufactured at no less than 1/10th of the intended commercial scale.

Data to support administration of omeprazole and sodium bicarbonate for oral suspension via nasogastric and orogastric tube is necessary to support this indication.