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Flonase Allergy Relief Exclusivity Sliced Up By Label Carve-Out

 
• By Malcolm Spicer

FDA grants Glaxo market exclusivity for OTC as the first OTC fluticasone product, but with a label carve-out that limits exclusivity to the indication of “OTC use for temporary relief of ocular symptoms due to hay fever or other upper respiratory allergies.”

GlaxoSmithKline PLC’s Flonase Allergy Relief is in stores as the first OTC fluticasone nasal spray with market exclusivity limited to an indication for eye-related allergy relief, allowing private label launches with a label carve-out before the exclusivity expires.

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More from United States

US FDA’s Advanced Manufacturing Designation Lifts Off With Cellares Cell Shuttle

 
• By Bridget Silverman

Cellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDA

FDA Reorganization Proposal A ‘Mindless Approach To Centralization,’ Woodcock Says

 
• By Sue Sutter

Plan to reorganize the agency into five offices was designed by someone who does not understand the FDA, former long-time agency official Janet Woodcock says. The proposal would eliminate highly specialized expertise in favor of “a big team of generalists,” former Principal Deputy Commissioner Joshua Sharfstein says.

US FDA Staff’s Union President Calls For More Support From Industry

 
• By Sarah Karlin-Smith

Industry should be more vocal about the harms the recent reduction-in-force will have on getting drugs to market, NTEU Chapter 282 President Anthony Lee said in an interview with Pink Sheet.

New US FDA Roadmap Moves Closer To Animal Testing Alternatives

 
• By Bridget Silverman

New plan to encourage alternatives to animal testing seeks interagency cooperation to meet more aggressive targets for transformational change than the US FDA’s long-standing program.

More from North America

HHS’ Kennedy Warns US FDA Staff Against ‘Agency Capture’ By Industry, Special Interests

 
• By Sue Sutter

HHS Secretary Robert F. Kennedy Jr. urged FDA staff to resist the “deep state” and “crony capitalism,” and focus on improving the health of America’s children. “You're not here to take orders,” he said and urged FDA staff to speak up if they see wrongdoing.

GLP-1 Drug Coverage Growing For Obesity In Medicaid, But Only For Diabetes In Medicare

 
• By Cathy Kelly

Coverage data from the two programs suggest Medicare beneficiaries may be more disappointed than Medicaid enrollees by the Trump Administration’s decision not to mandate the programs cover obesity drugs.

US FDA Allows Telework For Reviewers As Companies Detail Layoff-Related Problems

 
• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.