No a drug doesn’t need to have approval as a single agent to gain approval. Some drugs are designed to only work in combination with other drugs. A good example of this dexoroxane which is only approved for use with doxorubicin. On its own it does nothing, together with doxorubicin it helps prevent cardio toxicity.
Ann: Zantrene AML trial in Israel advances to Phase 2, page-131
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