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Everolimus · Regulatory approval
U.S. Food and Drug Administration · May 12, 2026
An action by a regulator. Authoritative on labelling and availability.
The FDA approved a generic everolimus formulation (ANDA218488) by Apotex on 12 May 2026, available in four oral tablet strengths (2.5, 5, 7.5, and 10 mg). This regulatory action confirms bioequivalence and manufacturing standards met FDA requirements for approval but does not report clinical efficacy, safety trials, or comparative benefits.
Regulatory approval.
Approval granted for everolimus tablets in four strengths: 2.5 mg, 5 mg, 7.5 mg, and 10 mg oral formulations. Sponsor: Apotex; Submission type: ORIG (original application).
This record does not contain clinical trial results, efficacy data, safety outcomes, or comparative effectiveness information. No information on indications, contraindications, or adverse event profile is provided in this regulatory record.
This approval provides regulatory confirmation of a generic everolimus product and does not itself constitute evidence of clinical efficacy or comparative benefit. Clinicians should refer to the original innovator NDA approvals and labeling for evidence of clinical use.
FDA approval of a generic everolimus formulation; confirms regulatory clearance but does not report clinical efficacy or comparative trial data.
Quoted from the source exactly as published.
This approval provides regulatory confirmation of a generic everolimus product and does not itself constitute evidence of clinical efficacy or comparative benefit. Clinicians should refer to the original innovator NDA approvals and labeling for evidence of clinical use.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Drugs@FDA record for application ANDA218488. This is a regulatory action record, not a clinical study. Brand name: EVEROLIMUS. Active ingredient: EVEROLIMUS. Sponsor: APOTEX. Submission type: ORIG (original application). Approval status date: 2026-05-12. Products: EVEROLIMUS, TABLET, ORAL, EVEROLIMUS 10MG; EVEROLIMUS, TABLET, ORAL, EVEROLIMUS 5MG; EVEROLIMUS, TABLET, ORAL, EVEROLIMUS 7.5MG; EVEROLIMUS, TABLET, ORAL, EVEROLIMUS 2.5MG.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.