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P&G Stretches ZzzQuil Sleep Brand Into Supplement Space With PureZzzs

 
• By Eileen Francis

P&G will launch Vicks ZzzQuil PureZzzs in late February as a drug-free, melatonin-based sleep aid, CFO Jon Moeller says. P&G hopes to reach $4.5bn in e-commerce sales in 2018, up from $3bn in 2017.

Procter & Gamble Co.'s latest extension of the "Vicks" and "Quil" roots of its consumer health brand enters the dietary supplement space with VicksZzzQuilPureZzzs, a melatonin sleep aid catering to the fast-growing market of consumers seeking natural remedies.

Chief Financial Officer Jon Moeller announced the PureZzzs launch on Jan

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Are Bigger Ad Policy Changes Coming After US FDA’s Drug Promotion Office Hit Hard By Layoffs?

 
• By Sue Sutter

The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.

US FDA Cites Taiho’s Lytgobi Healthcare Provider Website For Misleading Efficacy Claims

 
• By Sue Sutter

Results from a single-arm study cannot support representations on overall survival, progression-free survival and disease control rate for the cancer drug, the Office of Prescription Drug Promotion said in another “untitled” letter implicating the agency’s CFL guidance.

How To Leverage US FDA’s ‘Consistent With Labeling’ Guidance In DTC Ads

 
• By Sue Sutter

Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.

Ad/Promo: Improved Adherence Claim For Dexcel’s Hemady Not Supported, US FDA Says

 
• By Sue Sutter

A retrospective analysis does not support a claim that multiple myeloma patients are more adherent to Hemady than generic dexamethasone, OPDP said in an "untitled" letter suggesting increased enforcement focus on promotions leveraging the agency’s 2018 CFL guidance.

More from Compliance

Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
• By Eliza Slawther

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

Aragen’s CEO Says NIH Funding Cut Means Less R&D Money, And Tariffs Would Add To Woes

 
• By Vibha Ravi

Aragen’s CEO Manni Kantipudi, who is keenly watching the Trump Administration’s moves on pharma tariffs, discusses funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, and talks with the Indian government to solve intellectual property challenges in an audio interview.

US FDA Retirements Continue Unabated With Drug Inspectorate Leaders, Former Chief Counsel

 
• By Sue Sutter and Derrick Gingery

Alonza Cruse, director of the Office of Human and Animal Drugs Inspectorate, and two other senior inspection officials are departing, along with Mark Raza, chief counsel from 2021 until January.