Health (OTC Drugs)
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Regulation/Legislation Explore this Topic
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Latest From Regulation, Legislation & Health
US OTC Monograph Drug Facility Fees Up 8%, Higher Price Tags Stuck On OMORs, Too
FY2023 OTC monograph user fee target facility fee revenue is $25.4m from manufacturers’ fees of $26,153 and contract manufacturers’ fees of $17,435, all due by 1 June. OMOR fees are $517,381 for Tier 1 requests and $103,476 for Tier 2.
‘Stop Fighting' US FDA On Inspections As Food Safety Overhaul Brings ‘Big Change’ To Drug Systems – Califf
Commissioner Califf underscores need to keep inspections systems ‘tuned up’ to prevent manufacturers from ‘losing their edge’ on quality.
Errors Coughed Up For Dextromethorphan, Guaifenesin In US FDA Electronic Registrations
Three of seven businesses warned since February 2022 about noncompliance with FDA drug reporting requirements have been marketers of OTC cough/cold/congestion formulations made with dextromethorphan or guaifenesin.
US FDA Postpones Advisory Panel Meeting On Oral Phenylephrine GRASE
Change noted without elaboration in update to FDA announcement on Nonprescription Drugs Advisory Committee meeting. CHPA also notes change, saying it’s best for Industry and for consumers.
Haleon's Nick Tate: Tech Partnerships Key To Unlocking Digital Consumer Health Future
“There’s no one company, government, person or technology who is positioned to ‘solve’ the health of the world,” notes Haleon's Nick Tate. Which is why OTC companies are partnering with tech firms large and small to create the next generation of consumer healthcare products and services. In the first part of an exclusive interview on the future of digital consumer health, Tate – who heads up the firm’s incubator business, Haleon NEXT – discusses some of the complications of tech innovation that make such collaboration attractive.
California Prop 65 Complaints Against OTC Generics? Ranitidine Could Be First And Last Target
Marketers of copies of national brand OTCs are required under FDA regulations to use the same labeling as the brand, a rule that in effect has limited complaints in California state court alleging Prop 65 violations with nonprescription drug labeling to targeting branded product marketers.
Business Explore this Topic
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Latest From Deals & Health
Over The Counter 20 March 2023: The Shape Of The Global OTC Market To Come, With IQVIA Consumer Health's Amit Shukla
In this episode, HBW Insight catches up with IQVIA Consumer Health’s vice president of global consulting services, Amit Shukla, to find out how the global consumer healthcare market is performing as it comes out of the pandemic. It’s good news, Shukla reveals, based on the firm’s latest intelligence. The market grew double digits in 2022 and is predicted to expand by 5-6% per year in the future - even faster if some of the innovative switches currently in the pipeline succeed. Shukla points to artificial intelligence, sustainability and popular wellness ingredients as trends to watch that will drive future market growth.
Futura Launches Eroxon Erectile Dysfunction Gel In Europe, US Launch Delayed Until Q2 2023
European consumers can now buy Futura Medical's Eroxon erectile dysfunction gel without a prescription online, and in person via Belgian pharmacies. Further country launches, supported by advertising and promotional campaigns, remain on track during the coming months, Futura says. However, the US launch, expected for Q1 this year, has been delayed while the firm answers questions posed by the FDA.
Reaching 'Transformation' In Turnaround Phase 1, Perrigo Looks To Build On Its Accomplishments
Day after releasing Q4 and full-year results, Perrigo announced launch of next chapter in its “3/5/7” makeover strategy. It reached annual growth of 3% for top line revenues in phase 1, aims for 5% operating income and 7% earnings per share growth in phase 2.
Latest From Business Strategies & Health
US OTC Monograph Drug Facility Fees Up 8%, Higher Price Tags Stuck On OMORs, Too
FY2023 OTC monograph user fee target facility fee revenue is $25.4m from manufacturers’ fees of $26,153 and contract manufacturers’ fees of $17,435, all due by 1 June. OMOR fees are $517,381 for Tier 1 requests and $103,476 for Tier 2.
People On The Move: Appointments At GSCF, Bayer, Shop Apotheke
A round-up of the latest appointments in the consumer health industry: the Global Self-Care Federation elects J&J's Raghunandanan as its chair; Bayer Consumer Health makes changes to its medical leadership; and Shop Apotheke hires ex-DocMorris CEO to lead company.
Haleon’s Tess Player: Digital Self-Care Can Reduce Health Inequality And Raise Productivity
Haleon's partnership with Microsoft to include 1,500 of the former's products in the latter's Seeing AI application – which reads aloud information on packs for the visually impaired – is an example of how digitalization can help to make healthcare more inclusive, according to vice president and global head of healthcare professionals and health influencer marketing Tess Player.
Latest From Sales & Earnings & Health
Reaching 'Transformation' In Turnaround Phase 1, Perrigo Looks To Build On Its Accomplishments
Day after releasing Q4 and full-year results, Perrigo announced launch of next chapter in its “3/5/7” makeover strategy. It reached annual growth of 3% for top line revenues in phase 1, aims for 5% operating income and 7% earnings per share growth in phase 2.
Double-Digit Power Brand Growth Helps Haleon Beat Guidance In 2022
The growth of its nine power brands helped Haleon outstrip its sales guidance in 2022. While operating profit also improved, the firm was unable to hit its margin guidance, a miss it blamed on adverse transactional foreign currency.
Reckitt Records Impairment Charge For Biofreeze
Reckitt recorded a £152m impairment charge for Biofreeze in 2022 after the topical pain relief brand underperformed in the first half of the year. Despite issues for Biofreeze, Reckitt's Health business as a whole had a strong showing over the 12 months, with sales jumping by 19%.
Latest From Legal Issues & Health
California Prop 65 Complaints Against OTC Generics? Ranitidine Could Be First And Last Target
Marketers of copies of national brand OTCs are required under FDA regulations to use the same labeling as the brand, a rule that in effect has limited complaints in California state court alleging Prop 65 violations with nonprescription drug labeling to targeting branded product marketers.
Federal Preemption Strikes California Prop 65 Complaint Against Generic OTC Ranitidine Firms
Whether California court finds Zantac, when marketed containing ranitidine, should have had a Prop 65 label warning could be influenced by dismissal in federal court of class action complaints due to faulty research behind claims that ranitidine causes a carcinogenic substance to form post-production.
EUA For First At-Home Kit Differentiating COVID-19 From Flu Could Be Difference In Firm’s Survival
Sales authorized for first test providing at-home results including differentiating flu from COVID. Lucira gets EUA for its COVID-19 & Flu Test two days after filing for Chapter 11 bankruptcy protection, indicating it would seek buyer.
Marketing Explore this Topic
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Latest From Launches & Health
Health And Wellness Weekly Trademarks Review: 21 March
Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.
Health And Wellness Weekly Trademarks Review: 14 March
Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.
P&G Looks To Change Children’s Toothpaste Market With Crest Kids Color Changing
Color of the toothpaste, which P&G North America oral care chief says is “only one of its kind on the market today,” changes from blue to pink after two minutes of brushing.
Latest From Ad Campaigns & Health
P&G Looks To Change Children’s Toothpaste Market With Crest Kids Color Changing
Color of the toothpaste, which P&G North America oral care chief says is “only one of its kind on the market today,” changes from blue to pink after two minutes of brushing.
Futura Launches Eroxon Erectile Dysfunction Gel In Europe, US Launch Delayed Until Q2 2023
European consumers can now buy Futura Medical's Eroxon erectile dysfunction gel without a prescription online, and in person via Belgian pharmacies. Further country launches, supported by advertising and promotional campaigns, remain on track during the coming months, Futura says. However, the US launch, expected for Q1 this year, has been delayed while the firm answers questions posed by the FDA.
Bayer Wants Aspirin CVD Screening Tool To Reach 100m In US As It Plans International Roll-Out
Bayer hopes its innovative Aspirin-branded Heart Risk Assessment Tool will reach 100m in the US and its planning an international roll-out, the firm's general manager and vice president of pain and cardio, US, Kelly Fanning tells HBW Insight in an exclusive Q&A. Fanning also explains what Bayer is doing to manage the current surge in demand for Aspirin in the US, UK and Europe.
Latest From Ad Complaints & Health
US FTC Collects First ‘Review Hijacking’ Bounty Against Nestle’s Bountiful Supplement Business
FTC proposes order to settle administrative complaint requiring Bountiful Company to pay $600,000 monetary relief for consumers. Order prohibits the Nestle business from using “variation” relationships in e-commerce ads, when positive reviews posted for one product may be confused with a different but similar product.
ASA Stubs Out E-Cigarette Firm’s Smoking Cessation Claims
The UK's advertising regulator has ruled that government health statements cannot be used to support smoking cessation claims for unlicensed e-cigarettes.
Personal Care Next Target For UK Competition Authority ‘Greenwashing’ Audit
Manufacturers of UK personal care products watch out, the Competition and Markets Authority is on the look-out for false, exaggerated and/or vague sustainability claims, and may be targeting bigger players to make an example for the rest of the sector. And consumer health might be next. HBW Insight returns to advice from marketing expert Jo Stephenson on how to avoid greenwashing, based on the CMA's own extensive Green Claims Code.
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