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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

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.

User Fees OTC Drugs

‘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.

OTC Drugs Regulation

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.

FDA OTC Drugs

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.

Advisory Committees FDA

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.

United Kingdom 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.

OTC Drugs Legal Issues
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Business Explore this Topic

Set Alert for Business {Health}

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.

Health International

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.

Europe 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.

Sales & Earnings M & A
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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.

User Fees OTC Drugs

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.

Executive Changes Leadership

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.

International Health
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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.

Sales & Earnings M & A

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.

Europe Asia Pacific

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%.

Europe North America
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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.

OTC Drugs Legal Issues

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.

OTC Drugs US State News

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.

Coronavirus COVID-19 FDA
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Marketing Explore this Topic

Set Alert for Marketing {Health}

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.

OTC Drugs Trademarks

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.

OTC Drugs Trademarks

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.

Launches OTC Drugs
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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.

Launches OTC Drugs

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.

Europe Health

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.

International Middle East and Africa
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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.

Dietary Supplements E-Commerce

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.

United Kingdom Ad Complaints

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.

United Kingdom Beauty
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