For type 2 diabetes mellitus in multiple clinical settings. NDA 21073, held by Takeda Pharms USA. Pioglitazone Hydrochloride.
As of Nov 14, 2026, NDA 21073 (Actos), held by Takeda Pharms USA, was first approved by FDA on Jul 15, 1999, with 40 approved supplements and 0 published complete response letters.
Monotherapy and Combination Therapy ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. Important Limitations of Use ACTOS exerts its antihyperglycemic effect only in the presence of endogenous insulin. ACTOS should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease. ACTOS is a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma
| Dec 12, 2016 | Supplement 48Efficacy (new indication or use) · Standard review | Approved | |
| Feb 25, 2007 | Supplement 26Efficacy (new indication or use) · Standard review | Approved | |
| Nov 26, 2003 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Jan 17, 2003 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| Jul 12, 2002 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Jul 15, 1999 | Original applicationNew molecular entity · Priority review | Approved |
| ActosEQ 15MG BASE · tablet;oral | Pioglitazone Hydrochloride | RxReference drug |
| ActosEQ 30MG BASE · tablet;oral | Pioglitazone Hydrochloride | RxReference drug |
| ActosEQ 45MG BASE · tablet;oral | Pioglitazone Hydrochloride | RxReference drug |
| Dec 21, 2017 | Supplement 49Labeling · Standard review | Approved | |
| Dec 12, 2016 | Supplement 48Efficacy (new indication or use) · Standard review | Approved | |
| Nov 12, 2013 | Supplement 46Labeling | Approved | |
| Jun 27, 2013 | Supplement 47Manufacturing · Priority review | Approved | None posted |
| May 17, 2012 | Supplement 45REMS | Approved | |
| Aug 4, 2011 | Supplement 43REMS | Approved | |
| Aug 4, 2011 | Supplement 44Labeling | Approved | |
| Feb 3, 2011 | Supplement 35Labeling · Standard review | Approved | |
| Jul 29, 2010 | Supplement 40Labeling · Standard review | Approved | |
| Sep 9, 2009 | Supplement 37Labeling · Standard review | Approved | |
| Dec 11, 2008 | Supplement 34Labeling · Standard review | Approved | |
| May 7, 2008 | Supplement 33Labeling · Standard review | Approved | |
| Sep 6, 2007 | Supplement 30Labeling · Standard review | Approved | |
| Aug 14, 2007 | Supplement 31Labeling · Standard review | Approved | |
| Feb 25, 2007 | Supplement 26Efficacy (new indication or use) · Standard review | Approved | |
| Nov 4, 2006 | Supplement 28Labeling · Standard review | Approved | |
| Sep 28, 2006 | Supplement 29Labeling · Standard review | Approved | |
| Aug 30, 2006 | Supplement 27Labeling · Standard review | Approved | |
| Aug 3, 2004 | Supplement 23Labeling · Standard review | Approved | |
| Jul 20, 2004 | Supplement 24Labeling · Standard review | Approved | |
| Nov 26, 2003 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Jun 11, 2003 | Supplement 21Labeling · Standard review | Approved | |
| Jan 17, 2003 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| Dec 3, 2002 | Supplement 18Manufacturing · Priority review | Approved | |
| Oct 1, 2002 | Supplement 13Manufacturing · Priority review | Approved | |
| Jul 12, 2002 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Feb 28, 2002 | Supplement 15Manufacturing · Priority review | Approved | |
| Jan 7, 2002 | Supplement 16Labeling · Standard review | Approved | |
| Aug 3, 2001 | Supplement 14Manufacturing · Priority review | Approved | |
| Jul 6, 2001 | Supplement 8Manufacturing · Priority review | Approved | |
| Jul 6, 2001 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Jul 2, 2001 | Supplement 11Labeling · Standard review | Approved | None posted |
| May 22, 2001 | Supplement 12Manufacturing · Priority review | Approved | |
| Apr 25, 2001 | Supplement 7Manufacturing · Priority review | Approved | |
| Nov 3, 2000 | Supplement 6Manufacturing · Priority review | Approved | |
| Oct 25, 2000 | Supplement 4Manufacturing · Priority review | Approved | |
| Jul 26, 2000 | Supplement 5Manufacturing · Priority review | Approved | |
| Apr 11, 2000 | Supplement 3Manufacturing · Priority review | Approved | |
| Feb 25, 2000 | Supplement 1Manufacturing · Priority review | Approved | |
| Feb 25, 2000 | Supplement 2Manufacturing · Priority review | Approved | |
| Jul 15, 1999 | Original applicationNew molecular entity · Priority review | Approved |
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
