21 October 2003 16:39 [Source: ICIS news]
LONDON (CNI)--Novartis announced Tuesday it had received an approvable letter from the US Food and Drug Administration (FDA) for its transplant drug Certican.
Final approval is contingent on Novartis’ submission and FDA review of additional data, the Swiss life sciences group said.
Certican received its first approval from the Swedish Medical Products Agency in July this year. This means that Sweden is the reference member state for the mutual recognition process that is currently underway for Certican in the European Union (EU).
In Canada, the product received fast-track designation for use in heart transplant patients and is under review for use in kidney patients.
Certican is an immunosuppresant for use in kidney and heart transplantation. It targets the primary causes of chronic tissue rejection and infection, which Novartis said is a major unmet medical need in transplantation.
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