FDA's NDA And BLA Approvals: Mylotarg, Tracleer
Original new drugs and biologics recently approved by US FDA.
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Return to market for leukemia drug expected to generate another orphan drug exclusivity from new indication; Mylotarg also appears on track for 12-year biologics exclusivity after being approved as BLA, rather than an NDA as it was for its initial 2000 approval.
While the much-anticipated Innovative Medicines Fund is likely to benefit rare diseases in particular, other products must gain too.
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