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Endo Seeks To Block Generics Of Opana ER That Are Not Crush-Resistant

 
• By Brenda Sandburg

Endo citizen petition asks FDA to determine that the company’s old formulation was withdrawn for safety reasons and to decline approval of ANDAs of that formulation; Purdue Pharma files third OxyContin citizen petition.

Can a new crush resistant formulation of an opioid block FDA approval of a generic version of the non-crush resistant product?

That’s the question confronting FDA in a citizen petition submitted by Endo Pharmaceuticals Inc. The company requested...

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More from United States

More from North America

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

US FDA Asking Questions About Commissioner’s Voucher Program With Details Scarce

 
• By Derrick Gingery

FDA staff are trying to plan for program implementation in the absence of critical eligibility and other details, although guidance may be coming soon.

Senate Appropriators Give US FDA More Non-User Fee Funds Than House

 
• By Sarah Karlin-Smith

US FDA would receive more funding for fiscal year 2026 in the Senate appropriations bill than its House counterpart, including $10m for unannounced foreign inspections.