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Treats multiple inflammatory nodules with a diameter of 5 mm or greater. Sold as Accutane, Absorica, Absorica Ld. Every FDA application for this active ingredient: 3 branded and 16 generic.
As of Nov 15, 2026, FDA lists 19 applications for Isotretinoin (sold as Accutane, Absorica, Absorica Ld), first approved May 7, 1982, with 2 new uses approved and 0 published complete response letters.
First approved: May 7, 1982
Applications: 19
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $3.5M
Safety program: REMS
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Isotretinoin
Part D
$2.2M
+43%
3,860
Claravis
Part D
$527K
-11%
1,447
Zenatane
Part D
$470K
-13%
1,236
Amnesteem
Part D
$226K
+2%
599
Accutane
Part D
$58K
-17%
165
Absorica
Part D
$52K
+30%
16
What Pharmacies Pay
Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change
ISOTRETINOIN 10 MG CAPSULE: $4.21 per unitGeneric · -63% in a year
ISOTRETINOIN 20 MG CAPSULE: $4.18 per unitGeneric · -56% in a year
ISOTRETINOIN 25 MG CAPSULE: $10.59 per unitGeneric · -3% in a year
ISOTRETINOIN 30 MG CAPSULE: $5.43 per unitGeneric · -45% in a year
ISOTRETINOIN 40 MG CAPSULE: $5.83 per unitGeneric · -61% in a year
ABSORICA 20 MG CAPSULE: $35.74 per unitBrand · +1% in a year
ABSORICA 30 MG CAPSULE: $38.24 per unitBrand · +1% in a year
ABSORICA 40 MG CAPSULE: $38.22 per unitBrand · +0% in a year
ABSORICA LD 16 MG CAPSULE: $38.41 per unitBrand · -1% in a year
ABSORICA LD 24 MG CAPSULE: $42.23 per unitBrand · +2% in a year
ABSORICA LD 32 MG CAPSULE: $42.42 per unitBrand · +2% in a year
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
Mylan Pharms Inc
Sun Pharm Inds Ltd
Zydus Pharms
Aurobindo Pharma