Federal Register NoticeDermatology

FDA Approval: ABSORICA (ISOTRETINOIN) — Type 3 - New Dosage Form

FDA-NDA021951

Document details

Document type
Federal Register Notice
Issuing body
Office of the Federal Register / NARA
Document ID
FDA-NDA021951
Published
June 17, 2026
Effective date
May 25, 2012
MAC region
National

Summary

As ABSORICA (isotretinoin) is an oral drug, it will be billed under Medicare Part D. Given that it is a medication used for severe acne, prescribers should consider any prior authorizations or step th

New isotretinoin formulation impacts Part D billing policies.

Affected specialty

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Source document

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021951s000lbl.pdf

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