Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats newly diagnosed multiple myeloma (MM). Sold as Thalomid. Every FDA application for this active ingredient: 2 branded and 1 generic.
As of Nov 14, 2026, FDA lists 3 applications for Thalidomide (sold as Thalomid), first approved Jul 16, 1998, with 1 new use approved and 0 published complete response letters.
First approved: Jul 16, 1998
Applications: 3
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $17.2M
First approved in the EU: Apr 16, 2008
First approved in Japan: Oct 16, 2008
Safety program: REMS
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 123 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
ThaledDrugs with a new indication and a new dosage for the treatment of Crow-Fukase (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes… · Fujimoto Pharmaceutical Corporation · Feb 24, 2021 · Review report
ThaledDrugs with a new additional indication and a new dosage for the treatment of erythema nodosum leprosum. · Fujimoto Pharmaceutical Corporation · May 25, 2012
Thaled, new ingredientA drug containing a new active ingredient indicated for the treatment of relapsed or refractory multiple myeloma. · Fujimoto Pharmaceutical Corporation · Oct 16, 2008 · Review report
Safety Programs (REMS)
FDA requires these when a drug's risks need more than a label: training, enrollment or extra checks before it is prescribed or dispensed
Program
Updated
Thalidomide REMSRestricted: prescribers, pharmacies or patients must be certified or enrolled
Sep 2, 2026
Clinical Trials
47 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
