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Health (OTC Drugs)

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Regulation/Legislation Explore this Topic

Set Alert for Regulation and Legislation {Health}

Latest From Regulation, Legislation & Health

FDA Has Model Drug Facts Labels For OTC Naloxone, Wants Switch Proposals

Development of the model DFLs was a first for agency, reflecting alarm over public health crisis of overdoses from opioid abuse, which reached nearly 48,000 in 2017. The project was "part of our broader commitment to addressing the opioid crisis" and should help sponsors with potential naloxone OTC switch NDAs, says Commissioner Scott Gottlieb.

Prescription To Otc Switch Regulation

Octocrylene Now? Sunscreen Industry Under Growing Pressure As Environmental Concerns Mount

Lawmakers already are taking action to ban sales of oxybenzone- and octinoxate-containing sunscreens due to signals, however questionable, that the ingredients pose dangers to coral health. Now a new study suggests that octocrylene could be a concern as well.

Health Beauty

Irish $1.9bn Tax Bill 'Out Of Nowhere' Perplexes Perrigo, Troubles Analysts

Perrigo appeals tax assessment Ireland levied in late December on Rx ingredient royalty rights firm gained when it became incorporated in Dublin but no longer owns, Analysts allowed President and CEO Murray Kessler. benefit of doubt he'll lead Perrigo out of prolonged slump when he joined firm in November after extensive executive experience with tobacco firms and in other consumer goods markets, but they're more circumspect about its chances of prevailing in Irish tax disagreement.

Commercial Policy & Regulation

Lithuanian Liberalization ‘Justified,’ Says Vice-Minister of Health

A rush of retailers signing up to sell OTC medicines has suggested that Lithuania's decision to liberalize its OTC market was 'justified,' according to the country's Vice-Minister of Health Kristina Garuolienės. 
Health Regulation

Oral-B Enamel Repair Claim Has Second Brush With UK Advertising Authority

UK Advertising Standards Authority says despite P&G’s modification of a claim in TV ads for Oral B Gum and Enamel Repair toothpaste, visuals in the ad combined with claims suggest the product can repair enamel.

Regulation Commercial

2018 In Review: California, Hawaii Pass Personal-Care Legislation Among 300+ State Bills Overall

On par with 2017, the Personal Care Products Council was tracking more than 300 state bills last year with potential implications for its members, including measures ultimately enacted by California and Hawaii to deter cosmetic animal testing and ban environmentally questionable sunscreens.

Legislation Health
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Business Explore this Topic

Set Alert for Business {Health}

Latest From Deals & Health

Perrigo Expanding Consumer Portfolio After Finding Problems Slowing Growth

"Probably the worst offense" among Perrigo's problems is that before appointing President and CEO Murray Kessler in November, it had three CEOs since 2016, making him the fourth chief executive in three years, says Kessler. Perrigo's move to a self-care focus means "a broader emphasis on the wellness component of health and wellness" and opening its portfolio of products and categories to areas including nutraceuticals, oral care, probiotics, therapeutic skin care products and others.

Commercial OTC Drugs

Irish $1.9bn Tax Bill 'Out Of Nowhere' Perplexes Perrigo, Troubles Analysts

Perrigo appeals tax assessment Ireland levied in late December on Rx ingredient royalty rights firm gained when it became incorporated in Dublin but no longer owns, Analysts allowed President and CEO Murray Kessler. benefit of doubt he'll lead Perrigo out of prolonged slump when he joined firm in November after extensive executive experience with tobacco firms and in other consumer goods markets, but they're more circumspect about its chances of prevailing in Irish tax disagreement.

Commercial Policy & Regulation

Burt’s Bees Hopes Third Time’s A Charm For Toothpaste, This One With P&G

Clorox and Procter & Gamble embarked on a strategic licensing partnership to market Burt’s Bees toothpastes, available now in mass retail doors. Billed as simple formulas for adults and kids, with or without fluoride, the line marks the third swing at toothpaste for the iconic natural brand.

Health Deals
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Latest From Business Strategies & Health

FDA's OTC Naloxone Model Labels Confirmed In CONFER Study

Participants in FDA-commissioned CONFER study were scored on following label instructions for checking whether a potential patient has overdosed and administering a naloxone dose before calling for emergency help as well as on a "composite of cognitive walkthrough" of all those steps. Participants were in four groups: adult users of heroin and prescription opioids; those persons' friends and family members 18 years old and up; and separate groups of volunteers, 15- to 17-year-olds and adults.

Prescription To Otc Switch OTC Drugs

FDA Has Model Drug Facts Labels For OTC Naloxone, Wants Switch Proposals

Development of the model DFLs was a first for agency, reflecting alarm over public health crisis of overdoses from opioid abuse, which reached nearly 48,000 in 2017. The project was "part of our broader commitment to addressing the opioid crisis" and should help sponsors with potential naloxone OTC switch NDAs, says Commissioner Scott Gottlieb.

Prescription To Otc Switch Regulation

Reckitt Begins CEO Search As Kapoor Departs The Company He Reshaped

Reckitt Benckiser's long-serving CEO, Rakesh Kapoor, has unexpectedly announced his intention to retire by the end of the year, with the company immediately kicking off the search for his replacement. Kapoor will be remembered for transforming RB's consumer health business, but also for a number of setbacks under his watch which have impacted results.
Appointments Business Strategies
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Latest From Sales & Earnings & Health

Supply issues troubling Bayer Consumer Health

Bayer reported some encouraging third-quarter developments at its Consumer Health business, including the return to shelves of a key OTC brand in China. But there is still more to be done to complete the unit’s turnaround, says global Consumer Health head Heiko Schipper.

Health OTC Drugs

Sanofi’s growth balanced across all geographies

Sanofi enjoyed “balanced growth across all geographies and key categories” at its Consumer Healthcare business in the third quarter, noted group chief executive officer Olivier Brandicourt.

Health OTC Drugs

RB enjoys OTC growth ‘ahead of the market’

Reckitt Benckiser’s (RB’s) OTC business performed “materially ahead of the market” in the third-quarter of 2018, chief executive Rakesh Kapoor informed analysts on the firm’s earnings call.

Health OTC Drugs
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Latest From Legal Issues & Health

J&J CEO Sees Victory Ahead On Talc, Growth From Johnson's Relaunch

JP Morgan analysts had questions and J&J CEO Alex Gorsky and CFO Joseph Wolk had answers about liability suits alleging that use of the Johnson's brand talcum powder has caused mesothelioma or ovarian cancer. On the Johnson's brand outlook following its relaunch as a natural product line, Gorsky says sales were a key driver in the firm's consumer health sales in the 2018 third quarter. China, meanwhile, is a model for growing sales online, he says.
Legal Issues Ingredients

Keystone Labs Court-Ordered To Halt OTC Drug Manufacturing; Cosmetics Not Affected, It Says

Keystone Labs agrees to cease manufacturing OTC drugs following a 2013 FDA warning letter and repeated GMP violations noted during inspections, including failure to investigate sources of contamination. Firm suggests it will continue making cosmetic hair- and skin-care formulas while outsourcing OTC product manufacturing.

Legal Issues Manufacturing

OTC-Only PEG Market Nears After Court Passes On Stopping Rx ANDA Withdrawals

US circuit court rejects petitions from Breckenridge Pharmaceutical, Lannett Co., Nexgen Pharma and Paddock Labs to order FDA to conduct a hearing on their requests to sustain approvals for Rx PEG 3350 generics. FDA's approvals of the Rx ANDAs are set to expire Nov. 2; the agency said the Rx products were rendered unapproved in 2006 when the same formulation became available OTC.

Gastrointestinal Health
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Marketing Explore this Topic

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Latest From Launches & Health

Health Marketing Round-Up: January 2019

New OTC products and marketing campaigns in Germany, Australia and the UK.
Health OTC Drugs

Health And Wellness Product Weekly Trademark Review Jan. 8, 2019

Trademarks registered and published for opposition with UDPTO in Class 3 – cosmetics and cleaning Preps, and Class 5 –pharmaceuticals. Marks for vitamin, mineral and supplement products also are registered or published for opposition in both Class 3 and Class 5.

Dietary Supplements OTC Drugs

Starpharma’s Innovative VivaGel Condom Ready For Launch in Japan

Starpharma has received approval for its innovative VivaGel condom in Japan, which will be launched in the first half of 2019 by Okamoto Industries. 
OTC Devices Launches
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Latest From Ad Campaigns & Health

Gender Stereotypes in Ads Face Falling Foul Of New UK Regulations

Consumer health firms advertising in the UK - whether on television, online or through social media - will from June face tighter regulation aimed at protecting consumers from harmful gender stereotypes.

Ad Complaints United Kingdom

NiQuitin 'New Year, New You' Campaign Returns With Real-Life Quitter Testimonial

Perrigo's 'New Year, New You' UK campaign for its smoking cessation brand NiQuitin returns in 2019 with a new 'real life quitter' television spot. 
Health OTC Drugs
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Latest From Ad Complaints & Health

ASA Clears RB Of Misleading UK Consumers In Two Nurofen Ads

The UK's Advertising Standards Authority has cleared Reckitt Benckiser of misleading British consumers with two advertisements for its Nurofen brand of analgesics.
Health OTC Drugs

Oral-B Enamel Repair Claim Has Second Brush With UK Advertising Authority

UK Advertising Standards Authority says despite P&G’s modification of a claim in TV ads for Oral B Gum and Enamel Repair toothpaste, visuals in the ad combined with claims suggest the product can repair enamel.

Regulation Commercial

UK Nexium Ad Rapped For Downplaying Treatment For Persistent Heartburn

Pfizer’s TV ad for Nexium Control short-term heartburn treatment implied consumers with persistent heartburn need not seek professional medical advice, UK Advertising Standards Authority says. Pfizer argued that information in the ad was in line with MHRA's approval for the drug’s indications and packaging warned consumers not to use more than 14 days.

International United Kingdom
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