1. Pink Sheet
  2. >>Pathways & Standards
  3. >>Approval Standards

Indication 'Carve In' Allowed Under Generic Labeling 'Carve-Out' Authority, US FDA Says

 
• By Sue Sutter

In citizen petition response involving Takeda's Velcade, agency says ANDA and 505(b)(2) applicants may add more words to the indication statement in order to carve-out protected uses from the reference product's broadly written indication.

Carving a turkey
FDA carves up some succulent labeling.

The US FDA appears to have established a new "carve in" approach to "carving out" a reference product's protected uses from generic drug labeling in its recent response to a Takeda Oncology citizen petition on Velcade (bortezomib).

Velcade is currently indicated for treatment of patients with multiple myeloma and mantle cell lymphoma. These indications have been broadened...

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
Start Free Trial

Already a subscriber?

More from Approval Standards

Oncology: Plan Ahead To Rule Out Harm When Survival Not The Endpoint, US FDA Says

 
• By Michael McCaughan

The FDA recommended sponsors plan ahead for potential issues if overall survival is not feasible as a primary or secondary efficacy endpoint in clinical trials and must be analyzed as a safety outcome.

Selective Safety Data Collection In Clinical Trials: Adoption Lags Despite Benefits, US FDA Says

 
• By Manas Mishra

Lack of awareness is limiting use of guidelines that simplify safety reporting for some late-stage trials, FDA says, while also highlighting wins. Boehringer experienced mixed results, while Novartis, Lilly, and Merck were more successful, and Roche should have probably tried, white paper suggests.

COVID Vaccine Makers Should Be More Proactive On Study Designs, Countering Misinformation

 
• By Sue Sutter

Manufacturers should use of nontraditional, randomized study designs and rigorous observational approaches to counter concerns about safety and effectiveness in low-risk populations, while also doing more to respond to the public’s questions about mRNA technology, legal and medical experts said.

US FDA’s Latest Review Of Stealth’s Elamipretide Will Move With Speed

 
• By Kevin Grogan

The agency is expected to give its final verdict on the Barth syndrome drug by the end of September. Stealth is seeking accelerated approval based on the path forward outlined in the FDA's May 2025 complete response letter.

More from Pathways & Standards

Project Orbis: Annual UK Approvals Down Since 2022, But MHRA Touts Advantages

 
• By Eliza Slawther

The UK MHRA has emphasized the merits of the Project Orbis scheme, which has resulted in 12 new drug approvals and 14 indication extensions in the country so far. However, overall annual approval figures were lower in 2023 and 2024 than in the years prior.

Best Laid Plans: A Chronology Of Post-Pandemic COVID-19 Vaccines

 
• By Bridget Silverman

Quick responses to late-breaking changes to US FDA COVID-19 vaccine policy kept Novavax's Nuvaxovid and Moderna's mNexspike close to expected approval timelines despite revised indications and new post-marketing trial commitments.

Novaxovid And mNexspike Reviewers

 
• By Bridget Silverman

Pink Sheet Drug Review Profile feature listing FDA staff who conducted the reviews of Novavax and Moderna's post-pandemic COVID-19 vaccines