Withdrawn | Non-malignant Hematological, Neurological, and Other Disorder Indications Accelerated Approvals
This listing includes accelerated approvals (AAs) for non-malignant hematological, neurological, and other disorder indications that have postmarketing requirement(s) that have been subsequently withdrawn, and are therefore, no longer FDA-approved.
Withdrawn indications are not listed until FDA publishes a Federal Register notice to that effect or updates product labeling.
Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products. See Postmarket Requirements and Commitments for the status of specific requirements.
Visit Accelerated Approvals for listings of ongoing, verified clinical benefit, and withdrawn infectious diseases and non-malignant hematological, neurological, and other disorder indications accelerated approvals.For the treatment of alzheimer’s disease
| Drug Name | Accelerated Approval Indication | Accelerated Approval Date | Full Approval Conversion-Withdrawal Date |
|---|---|---|---|
| Ocaliva3 (Obeticholic Acid) | For the treatment of primary biliary cholangitis (pbc) in combination with ursodeoxycholic acid (udca) in adults with an inadequate response to udca, or as monotherapy in adults unable to tolerate udca | 5/27/2016 | 11/24/2025 |
| Ocaliva3 (Obeticholic Acid) | For the treatment of primary biliary cholangitis (pbc) in combination with ursodeoxycholic acid (udca) in adults with an inadequate response to udca, or as monotherapy in adults unable to tolerate udca | 5/27/2016 | 11/24/2025 |
| Ocaliva3 (Obeticholic Acid) | For the treatment of primary biliary cholangitis (pbc) in combination with ursodeoxycholic acid (udca) in adults with an inadequate response to udca, or as monotherapy in adults unable to tolerate udca | 5/27/2016 | 11/24/2025 |
| Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo) | For patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding | 5/3/2018 | 12/23/2025 |
| Elevidys (delandistrogene moxeparvovec-rokl) | to expand the approved indication to individuals at least 4 years of age for the treatment of Duchenne muscular dystrophy (DMD) in patients who are non-ambulatory and have a confirmed mutation in the DMD gene. | 6/20/2024 | 1/12/2026 |
| Aduhelm (aducanumab-avwa) | For the treatment of alzheimer’s disease | 6/7/2021 | 11/1/2024 |
| Makena 2 (hydroxyprogesterone caproate) | To reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth | 2/3/2011 | 4/6/2023 |
| Makena 2 (hydroxyprogesterone caproate) | To reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth | 2/3/2011 | 4/6/2023 |
| Ethyol (amifostine) | To reduce cumulative renal toxicity associated with repeated adminstations of cisplatin in patients with non-small cell lung cancer | 3/15/1996 | 3/28/2006 1 |
| Luveris (lutropin alpha) | Concomitantly administered with gonal-f (follitropin alfa for injection) for stimulation of follicular development in infertile hypogonadotropic hypogonadal women with profound lh deficiency (lh < 1.2 iu/l) | 10/8/2004 | 4/12/2016 |
1 Date of the labeling supplement approval that removed this indication.
2 The two entries for Makena represent two different postmarketing requirements that were released when Makena was withdrawn. For more information, see https://www.fda.gov/news-events/press-announcements/fda-commissioner-and-chief-scientist-announce-decision-withdraw-approval-makena.
3 The three entries for Ocaliva represent three different postmarketing requirements that were released when Ocaliva was withdrawn. For more information, see the Federal Register.