Pomalidomide

Sold as Pomalyst. Every FDA application for this active ingredient: 1 branded and 11 generic.

As of Nov 13, 2026, FDA lists 12 applications for Pomalidomide (sold as Pomalyst), first approved Feb 8, 2013, with 4 new uses approved and 0 published complete response letters.

First approved: Feb 8, 2013
Applications: 12
New uses approved: 4
Complete response letters: 0
Medicare spending, 2025: $2.32B

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Pomalyst	Part D	$2.32B	+8%	14,946
Pomalidomide	Part D	$0K	New	0

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Feb 8, 2013	PomalystNDA 204026 · New molecular entity	Bristol	26	Marketed
Oct 30, 2020	PomalidomideANDA 210111	Breckenridge	2	Marketed
Oct 30, 2020	PomalidomideANDA 210249	Eugia Pharma	5	Marketed
Jan 26, 2022	PomalidomideANDA 210275	Mylan	3	Discontinued
May 4, 2022	PomalidomideANDA 209956	Teva Pharms USA	3	Marketed
Jun 11, 2024	PomalidomideANDA 210164	Apotex	2	Marketed
Sep 26, 2024	PomalidomideANDA 210236	Hetero Labs Ltd V	2	Marketed
Aug 31, 2026	PomalidomideANDA 210232	Spil	0	Marketed
Aug 31, 2026	PomalidomideANDA 213234	Dr Reddys	0	Marketed
Aug 31, 2026	PomalidomideANDA 219718	Cipla	0	Marketed
Aug 31, 2026	PomalidomideANDA 220741	Sandoz	0	Marketed
Sep 2, 2026	PomalidomideANDA 210245	Msn	0	Marketed

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. Drugs@FDA