FDA Shuts The Door On Celgene’s Abraxane Petition

Petition Filed In 2015 Could Have Delayed Competition

ANDA and 505(b)(2) sponsors have been handed a boost after the FDA denied almost entirely a citizen petition filed by Bristol Myers Squibb’s Celgene which called for additional tests for rivals to its Abraxane oncology agent.

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The FDA mostly denied the 2015 petition • Source: Shutterstock

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