Nesina

For type 2 diabetes mellitus. NDA 22271, held by Takeda Pharms USA. Alogliptin Benzoate.

As of Nov 14, 2026, NDA 22271 (Nesina), held by Takeda Pharms USA, was first approved by FDA on Jan 25, 2013, with 12 approved supplements and 0 published complete response letters.

First approved: Jan 25, 2013
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Alogliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below


Jul 27, 2023	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Label Medication Guide Letter
Apr 5, 2016	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 25, 2013	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Letter Label

Products

3 strengths and forms


NesinaEQ 6.25MG BASE · tablet;oral	Alogliptin Benzoate	RxReference drug
NesinaEQ 12.5MG BASE · tablet;oral	Alogliptin Benzoate	RxReference drug
NesinaEQ 25MG BASE · tablet;oral	Alogliptin Benzoate	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Jul 27, 2023	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Label Medication Guide Letter
Mar 11, 2022	Supplement 13Labeling · Standard review	Approved	Label Letter
Jul 1, 2019	Supplement 12Labeling	Approved	Label Letter
Dec 12, 2016	Supplement 11Labeling · Standard review	Approved	Label Letter
May 27, 2016	Supplement 9Labeling · Standard review	Approved	Label Letter
Apr 19, 2016	Supplement 8Manufacturing · Standard review	Approved	None posted
Apr 5, 2016	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 28, 2015	Supplement 7Labeling	Approved	Label Letter
Jul 20, 2015	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 15, 2013	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 26, 2013	Supplement 2Manufacturing · Standard review	Approved	None posted
May 30, 2013	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 25, 2013	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22271
Drugs@FDA: Overview at FDA
Company: Takeda Pharmaceuticals USA

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters