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FDA approval · 2014-02-12

FDA Approved: IMBRUVICA — Original Application (Pharmacyclics LLC)

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Summary

The FDA granted the original approval of Imbruvica (ibrutinib) to Pharmacyclics LLC under NDA205552, marking its first approval for mantle cell lymphoma.

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Diseases / indications

Drugs mentioned

  • IMBRUVICA (IBRUTINIB)

Snippet

ORIG AP for IMBRUVICA (IBRUTINIB)