Withdrawn | Non-malignant Hematological, Neurological, and Other Disorder Indications Accelerated Approvals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neurological, and other disorder indications that have postmarketing requirement(s) that have been subsequently withdrawn, and are therefore, no longer FDA-approved.
Withdrawn indications are not listed until FDA publishes a Federal Register notice to that effect or updates product labeling.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Visit Accelerated Approvals for listings of ongoing, verified clinical benefit, and withdrawn infectious diseases and non-malignant hematological, neurological, and other disorder indications accelerated approvals.
| Drug Name | Accelerated Approval Indication | Accelerated Approval Date | Full Approval Conversion-Withdrawal Date |
|---|---|---|---|
| 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