Treats thrombocythemia, secondary. NDA 20333, held by Takeda Pharms USA. Anagrelide Hydrochloride.
As of Nov 13, 2026, NDA 20333 (Agrylin), held by Takeda Pharms USA, was first approved by FDA on Mar 14, 1997, with 23 approved supplements and 0 published complete response letters.
AGRYLIN is indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. AGRYLIN is a platelet reducing agent indicated for the treatment of thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events.
| Dec 10, 2004 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Dec 16, 1998 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Mar 14, 1997 | Original applicationNew molecular entity · Priority review | Approved |
| AgrylinEQ 0.5MG BASE · capsule;oral | Anagrelide Hydrochloride | Rx |
| AgrylinEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Anagrelide Hydrochloride | DiscontinuedReference drug |
| Oct 13, 2021 | Supplement 27Labeling · Standard review | Approved | |
| Feb 28, 2020 | Supplement 26Labeling · Standard review | Approved | |
| Dec 19, 2018 | Supplement 25Labeling · Standard review | Approved | |
| Mar 20, 2018 | Supplement 24Labeling · Standard review | Approved | |
| Jul 14, 2015 | Supplement 23Labeling · Standard review | Approved | |
| Oct 30, 2014 | Supplement 22Labeling · Standard review | Approved | |
| Feb 7, 2014 | Supplement 21Labeling · Standard review | Approved | |
| Jul 17, 2013 | Supplement 20Labeling · Standard review | Approved | |
| Nov 22, 2011 | Supplement 19Labeling · Standard review | Approved | |
| Jan 31, 2011 | Supplement 17Labeling | Approved | |
| Jun 30, 2010 | Supplement 16Labeling | Approved | |
| Jul 9, 2009 | Supplement 15Labeling · Standard review | Approved | |
| Jun 17, 2008 | Supplement 13Labeling · Standard review | Approved | |
| Dec 17, 2004 | Supplement 10Labeling · Standard review | Approved | |
| Dec 10, 2004 | Supplement 9Labeling · Standard review | Approved | |
| Dec 10, 2004 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Oct 10, 2002 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Mar 15, 2002 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Nov 3, 2000 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Mar 13, 2000 | Supplement 4Labeling · Standard review | Approved | None posted |
| Aug 19, 1999 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Dec 16, 1998 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Nov 7, 1997 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Mar 14, 1997 | 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
