Trapped by orphan drug rules, FDA blocks generic Treanda for 3 extra years

26th February 2019 Uncategorised 0

FDA’s own rules for rare disease drugs have forced it to extend Eagle Pharma’s exclusivity on Treanda, even though the cancer therapy itself doesn’t meet orphan drug criteria. The “illogical” three-year reprieve from generics could cost the public $3 billion, one analyst said.

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Source: fierce