FDA Shuts The Door On Celgene’s Abraxane Petition

Petition Filed In 2015 Could Have Delayed Competition

09 Jul 2021

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.

FDA_Truck — The FDA mostly denied the 2015 petition • Source: Shutterstock

The US Food and Drug Administration has mostly denied a citizen petition filed by Celgene requesting the agency add new requirements for generic sponsors developing rivals to the originator’s Abraxane (protein-bound paclitaxel) for injectable suspension, as part of an attempt to delay competition to the complex treatment for forms of cancer.

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