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Smoking Cessation Label Changes Could Lay Groundwork For Indications

 
• By Lisa Gillespie and Malcolm Spicer

FDA drops its requirement for labeling provisions for NRTs on duration of use and concomitant use of tobacco or other NRTs. Meanwhile, the agency rejects citizen petition requests for additional NRT indications, but says it is open to working with sponsors on developing those indications.

FDA will allow OTC nicotine replacement therapy products to drop duration-of-use limits and warnings about concomitant use with other cessation products from labeling, laying potential groundwork for eventual expansion of NRT indications.

However, the agency denied requests to expand NRT indications, made in multiple citizen petitions, in a letter released...

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More from United States

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Animal Testing: US And EU Regulatory Support Grows For Alternatives, But Validation A Hurdle

 
• By Eliza Slawther

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More from North America

Senate Panel Approves US CDC Director Candidate Monarez With Measles Outbreak Growing

 
• By Cathy Kelly

The Senate Health, Education, Labor and Pensions Committee voted to advance Monarez's nomination to lead the CDC as the agency announced the largest US measles outbreak in 22 years.

US FDA Advisory Committee Supports Vaccine Safety, Scrutinizes AE Reporting Quality

 
• By Sue Sutter

The Pediatric Advisory Committee supported routine safety monitoring for three vaccines and 21 drugs, but the panel’s consumer representative said adverse event reporting needs improvement and FDA literature reviews should include lawsuits as well as social media.

US FDA Will Not Pull Teva And MSN Hetlioz ANDAs, Rejects Vanda Citizen Petitions

 
• By Dean Rudge

The FDA concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements and there was no “mistake” or untrue statement in the original ANDA approvals.