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Copaxone Generics: FDA Approval Standards Defy Teva’s Argument On Complexity

 
• By Sue Sutter

Sandoz/Momenta’s Glatopa (glatiramer) met four criteria for equivalence that ‘provide overlapping and confirmatory evidence of active ingredient sameness,’ FDA says.

FDA approval of Sandoz Inc. and Momenta Pharmaceuticals Inc.’s Glatopa (glatiramer), the first generic of Teva Pharmaceutical Industries Ltd.’s Copaxone, came with a road map for demonstrating active ingredient sameness to the structurally complex multiple sclerosis drug.

The agency disagreed with Teva’s arguments in a series of citizen petitions that Copaxone’s complexity and structure preclude a determination...

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More from United States

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Complete Response Letters: Will Industry Fight US FDA’s Disclosure Plans?

 
• By Sue Sutter

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Pink Sheet Podcast: US FDA Drops Offit From Adcom, Releases Unapproved Product CRLs

 
• By Derrick Gingery, Bridget Silverman, Sue Sutter, and Nielsen Hobbs

Pink Sheet editors discuss the recent departure of a noted vaccine expert and many others from FDA advisory committee rosters, as well as the details and potential impact of the FDA’s release of dozens of complete response letters for unapproved products.

More from North America

89 Complete Response Letters For Unapproved Drugs, One Huge Leap For US FDA Transparency

 
• By Bridget Silverman

The US FDA’s unprecedented publication of 89 recent CRLs for unapproved products comes with a promise to release future letters more promptly.

Kennedy Maintains mRNA Negativity Even When Couched As Trump Success

 
• By Sarah Karlin-Smith

The Health and Human Services Secretary's Sept. 4 appearance at the Senate Finance Committee also revealed more Republicans are souring on his vaccine policies, although most still support him.

US FDA’s New ‘Plausible Mechanism Of Action’ Pathway Limited To Bespoke Therapies

 
• By Sue Sutter

Center for Biologics Evaluation and Research Director Vinay Prasad and Commissioner Martin Makary will introduce the new pathway soon in a New England Journal of Medicine article.