November 14, 1983

Ciclosporin

FDA formally approves Sandimmune cyclosporine products

The formal approval covered a vial and a liquid — not the Sandimmune capsules that patients later knew.

Two applications, 14 November 1983

FDA’s current Drugs@FDA record assigns 14 November 1983 to the original approval of Sandimmune injectable cyclosporine, NDA 050573, classed as a priority Type 1 new molecular entity. The federal administrative record adds the oral solution, NDA 50-574, on the same date.

The indication was prevention of rejection in heart, kidney and liver transplants. Strengths were 50 mg/mL injectable and 100 mg/mL oral solution; the familiar soft-gel capsule application came later, in 1990.

One source says September

A contemporary Washington Post report dated 3 September 1983 said FDA commissioner Arthur Hull Hayes Jr. had approved cyclosporine on 2 September.

The surviving sources do not fully explain the gap. 14 November is best treated as the formal product and NDA action date rather than unquestionably the first FDA authorization announcement.

The drug was already five years into patients

Approval did not create the therapy. Roy Calne’s Cambridge team had begun clinical solid-organ trials in 1978 and U.S. investigational trials followed in 1979; Thomas Starzl developed the cyclosporine-plus-low-dose-steroid approach that improved the balance between rejection control and toxicity.

What 14 November changed was availability: cyclosporine moved from limited clinical investigation to a generally marketable U.S. transplant medicine.

It did not eliminate rejection or toxicity either. The label requires specialist supervision and monitoring and warns of nephrotoxicity, infection and lymphoma risks.

Sources

Researched 24 Aug 2026 8 sources not yet audited Date disputed

How this was checked

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Date disputed. Sources disagree about when this happened.

What the sources leave uncertain

FDA's present Drugs@FDA database, later Orange Book records and a federal-court account of the administrative record all give 14 November 1983 as the formal NDA approval date.
A contemporary Washington Post report dated 3 September 1983 said FDA commissioner Arthur Hull Hayes Jr. had approved cyclosporine on 2 September. The surviving sources do not fully explain the gap; 14 November is therefore best treated as the formal product/NDA action date rather than unquestionably the first FDA authorization announcement.