Oseni

For type 2 diabetes mellitus. NDA 22426, held by Takeda Pharms USA. Alogliptin Benzoate; Pioglitazone Hydrochloride.

As of Nov 14, 2026, NDA 22426 (Oseni), held by Takeda Pharms USA, was first approved by FDA on Jan 25, 2013, with 10 approved supplements and 0 published complete response letters.

First approved: Jan 25, 2013
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

OSENI is 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 11 submissions below


Dec 12, 2016	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter
Apr 5, 2016	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 25, 2013	Original applicationNew combination · Standard review	Approved	Review Label Letter Other

Products

6 strengths and forms


OseniEQ 25MG BASE;EQ 15MG BASE · tablet;oral	Alogliptin Benzoate; Pioglitazone Hydrochloride	RxReference drug
OseniEQ 25MG BASE;EQ 30MG BASE · tablet;oral	Alogliptin Benzoate; Pioglitazone Hydrochloride	RxReference drug
OseniEQ 25MG BASE;EQ 45MG BASE · tablet;oral	Alogliptin Benzoate; Pioglitazone Hydrochloride	RxReference drug
OseniEQ 12.5MG BASE;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Alogliptin Benzoate; Pioglitazone Hydrochloride	DiscontinuedReference drug
OseniEQ 12.5MG BASE;EQ 30MG BASE · tablet;oral	Alogliptin Benzoate; Pioglitazone Hydrochloride	RxReference drug
OseniEQ 12.5MG BASE;EQ 45MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Alogliptin Benzoate; Pioglitazone Hydrochloride	DiscontinuedReference drug

All 11 submissions, including labeling and manufacturing supplements


Jun 28, 2024	Supplement 16Labeling · Standard review	Approved	Letter Label Medication Guide
Mar 11, 2022	Supplement 14Labeling · Standard review	Approved	Label Letter
Jul 1, 2019	Supplement 12Labeling	Approved	Label Letter
Dec 21, 2017	Supplement 10Labeling · Standard review	Approved	Letter Label
Dec 12, 2016	Supplement 9Labeling · Standard review	Approved	Label Letter
Dec 12, 2016	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter
Apr 5, 2016	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 17, 2016	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 28, 2015	Supplement 5Labeling	Approved	Label Letter
Aug 15, 2013	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 25, 2013	Original applicationNew combination · Standard review	Approved	Review Label Letter Other

Identifiers

Application: NDA 22426
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