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  8. Withdrawn | Non-malignant Hematological, Neurological, and Other Disorder Indications Accelerated Approvals
  1. Accelerated Approval Program

Withdrawn | Non-malignant Hematological, Neurological, and Other Disorder Indications Accelerated Approvals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neurological, and other disorder indications that have postmarketing requirement(s) that have been subsequently withdrawn, and are therefore, no longer FDA-approved.

Withdrawn indications are not listed until FDA publishes a Federal Register notice to that effect or updates product labeling.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Visit Accelerated Approvals for listings of ongoing, verified clinical benefit, and withdrawn infectious diseases and non-malignant hematological, neurological, and other disorder indications accelerated approvals.For the treatment of alzheimer’s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 NameAccelerated Approval IndicationAccelerated Approval DateFull Approval Conversion-Withdrawal Date
Aduhelm (aducanumab-avwa)For the treatment of alzheimer’s disease6/7/202111/1/2024
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 birth2/3/20114/6/2023
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 birth2/3/20114/6/2023
Ethyol (amifostine)To reduce cumulative renal toxicity associated with repeated adminstations of cisplatin in patients with non-small cell lung cancer3/15/19963/28/2006 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)10/8/20044/12/2016

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2 The two entries for Makena represent two different postmarketing requirements that were released when Makena was withdrawn.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.

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