The Short And Controversial Life Of Zohydro Comes To An End

US FDA’s approval of the opioid over resounding opposition of an advisory committee has haunted the agency, and it has imperiled both of Robert Califf’s nominations to be commissioner. The latest company to own Zohydro stopped selling it and FDA withdrew approval of its NDA.

Zohydro ER tombstone
Zohydro (hydrocodone bitartrate) has been withdrawn from the market • Source: Nielsen Hobbs; the Pink Sheet | Alamy images

The quiet end for Zohydro ER – buried in a list of drugs whose approvals are being withdrawn by the US FDA – belies the turmoil the opioid created for the agency.

FDA announced in a Federal Register notice to be published on 2 February that it is withdrawing approval of...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from US FDA

US FDA To Advisory Committee Industry Reps: Don’t Talk Too Much

 
• By 

Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.

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

 

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.

US FDA Staff Stability Should Be A Congressional Priority, Former Chief Of Staff Says

 

Lawmakers should address FDA staff upheaval and help the agency “get back on track,” former agency Chief of Staff Elizabeth Jungman said, while CBER Director Vinay Prasad told staff he is asking ex-colleagues to return to the agency.

US FDA ‘Commissioner’s Voucher’ As Public Relations Tool

 

NRx Pharma is trying to capitalize on the headlines about a new US FDA hyper-fast review program, illustrating that the lack of details in the FDA’s announcement is an opening for sponsors to try to grab some attention.

More from Agency Leadership

US FDA Staff Stability Should Be A Congressional Priority, Former Chief Of Staff Says

 

Lawmakers should address FDA staff upheaval and help the agency “get back on track,” former agency Chief of Staff Elizabeth Jungman said, while CBER Director Vinay Prasad told staff he is asking ex-colleagues to return to the agency.

US FDA ‘Commissioner’s Voucher’ As Public Relations Tool

 

NRx Pharma is trying to capitalize on the headlines about a new US FDA hyper-fast review program, illustrating that the lack of details in the FDA’s announcement is an opening for sponsors to try to grab some attention.

HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
• By 

A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.