Federal Register NoticeInfectious Disease

FDA Approval: MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) — Type 4 - New Combination

FDA-NDA021078

Document details

Document type
Federal Register Notice
Issuing body
Office of the Federal Register / NARA
Document ID
FDA-NDA021078
Published
June 13, 2026
Effective date
July 14, 2000
MAC region
National

Summary

As a newly approved oral drug, Malarone will be billed under Medicare Part D. Since it is a combination therapy for malaria, billing teams should note potential variations in coverage and reimbursemen

Malarone approved for malaria treatment under Medicare Part D.

Affected specialty

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Source document

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-078_Malarone_Prntlbl.pdf

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