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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 Proposed ACNU Rule Rings Bell About Rx Drugs Marketed After NDAs Eliminated With OTC Switches

Proposal for simultaneous Rx and OTC sales of same drug at same dose and indication has CHPA hoping FDA acknowledges Pataday and Voltaren Arthritis Relief are competing with Rx equivalents even though elimination of prescription NDAs was part of approvals for the two switches.

FDA Prescription To OTC Switch

Ireland Reviewing Codeine's OTC Status

Ireland’s drug regulator HPRA has initiated a formal regulatory procedure to determine if OTC remains the appropriate classification for codeine-containing products. The agency says the move is in response to a growing understanding of the potential impacts of addiction to codeine at low doses.

Drug Review Drug Safety

‘Fail First’ Requirement In ACNU Proposal Prompts Adverse Reactions Across US Drug Industry

PhRMA captures tone of its comments saying “proposed rule might play an important role” in making more drugs available OTC. AAM also references gauntlet, saying proposed pathway “would, in theory, broaden the types of nonprescription drugs available to consumers.” CHPA discusses same concerns as well as additional questions for FDA.

Prescription To OTC Switch FDA

Approved Nearly 75 Years Ago, Bufferin NDA On Withdrawal Notice Due To Registration Lapse

Attention must be paid when withdrawal is for NDA approved in 1948 for brand synonymous with nonprescription pain relief, Bufferin. Even when FDA’s decision amounts to NDA database recordkeeping, withdrawal of application demands notice in US OTC space.

OTC Drugs Drug Approval Standards

Estonia Ends OTC Access To Codeine

Concerns over addiction to, and deliberate misuse of, codeine in Estonia has led the national regulator to reverse-switch the opioid from OTC to prescription-only status.

Estonia Drug Safety

Canada Responds To Children’s OTC Pain Reliever Shortage Linked To Consumers ‘Panic Buying’

Shortage began in August and has increased the onset of cough/cold season due to consumers’ “stockpiling/panic buying” in response to high levels of activity in COVID-19, RSV, seasonal flu and other viruses, according to Canadian Pharmacists Association. Health Canada has approved imports of Haleon and J&J children’s pain relievers.

Coronavirus COVID-19 OTC Drugs
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Business Explore this Topic

Set Alert for Business {Health}

Latest From Deals & Health

Viatris Puts OTC Business Up For Sale

Viatris has decided to exit the consumer health market and has put up for sale an OTC business which is thought to generate around $1.0bn in annual sales.

Business Strategies Health

Haleon Establishing Own Distribution In India To Unleash Growth

Haleon is taking back full control of its interests in India by terminating a distribution deal for its OTC and oral care brands signed with Hindustan Unilever in 2020.

Business Strategies India

Alfasigma Signals Consumer Health Ambitions With Sofar Acquisition

By acquiring fellow Italian manufacturer Sofar, Alfasigma expands its consumer health footprint and adds products and expertise in its priority gastrointestinal category.

Deals Business Strategies
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Latest From Business Strategies & Health

US Proposed ACNU Rule Rings Bell About Rx Drugs Marketed After NDAs Eliminated With OTC Switches

Proposal for simultaneous Rx and OTC sales of same drug at same dose and indication has CHPA hoping FDA acknowledges Pataday and Voltaren Arthritis Relief are competing with Rx equivalents even though elimination of prescription NDAs was part of approvals for the two switches.

FDA Prescription To OTC Switch

Teva Appoints Former Sandoz CEO Francis To Replace Schultz

Teva will soon have a new president and CEO with former Sandoz chief Richard Francis announced as Kåre Schultz’s replacement from the start of 2023.

Executive Changes Leadership

OTC Marketing Awards 2022: What The Judges Said About The Leading Entries

The trophies have been handed out at the OTC Marketing Awards 2022 - but what did the expert judges have to say about the winning and highly-commended entries?

Innovation Ad Campaigns
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Latest From Sales & Earnings & Health

Germany's PharmaSGP Raises Sales Guidance In 'Record Year'

European Consumer health player PharmaSGP is well on the way to achieving new record revenues in 2022, and is working to maintain this upward trajectory over the medium and long term. 

Europe Health

Taisho Boosted By Overseas Sales With Japanese Business Flat

Taisho's Self-Medication business posted a solid gain in the six months ended 30 September as a recovery in its Overseas operation boosted a flat performance in Japan.

Japan Europe

Haleon Raises Sales Guidance But Warns Of Tougher Q4

While Haleon expects 2022 sales to grow by around 8%, the UK-based consumer health giant faces a more difficult end to the year as it begins to cycle over significant price increases rolled out towards the end of 2021.

Sales & Earnings OTC Drugs
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Latest From Legal Issues & Health

Coppertone Sunscreen 'Pure & Simple'? Class Action Plaintiff Begs To Differ

Plaintiff Mark Ballotti alleges that 17 of 24 ingredients in Coppertone Pure & Simple SPF 50 Mineral Lotion are neither pure nor simple, “because they are made by mixing with other substances and materials and significantly modified,” in his complaint filed in Illinois’ Northern District.

Legal Issues Advertising, Marketing & Sales

Unilever Recalls More Personal-Care Products That May Contain Benzene

The firm has instructed retailers to remove, and consumers not to use, selected lots of dry shampoo aerosol products from Dove, Nexxus, Suave, TIGI and TRESemme. The voluntary action follows Unilever’s recall of Suave aerosol antiperspirants in March, also due to potential benzene contamination.

Recalls Legal Issues

Bankruptcy Court Stakes Authority In J&J Litigation As States Push For Talc Damages Claims

Complaints by Mississippi and New Mexico allege J&J failed to protect consumers from asbestos-containing talc temporarily stayed by bankruptcy judge in New Jersey. House Appropriations chair DeLauro asks for information from DoJ investigation.

Cosmetics OTC Drugs
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Marketing Explore this Topic

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Latest From Launches & Health

OTC Marketing Awards 2022: What The Judges Said About The Leading Entries

The trophies have been handed out at the OTC Marketing Awards 2022 - but what did the expert judges have to say about the winning and highly-commended entries?

Innovation Ad Campaigns

Haleon Voted Company Of The Year At The OTC Marketing Awards 2022

Winners across 15 categories were announced at the OTC Marketing Awards 2022 on 28 November, with Haleon crowned OTC Company of the Year.

Ad Campaigns Launches

Bayer Extends Afrin Line With First OTC Oxymetazoline Spray In US For Children Under 6

Children’s Afrin regular and no-drip formulations reach US stores with consumers having choices between dozens of oxymetazoline nasal sprays available under an FDA OTC monograph. But products indicated for children was limited to one, Mucinex Childrens Stuffy Nose, and it’s for children 6 and up.

OTC Drugs Launches
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Latest From Ad Campaigns & Health

OTC Marketing Awards 2022: What The Judges Said About The Leading Entries

The trophies have been handed out at the OTC Marketing Awards 2022 - but what did the expert judges have to say about the winning and highly-commended entries?

Innovation Ad Campaigns

Haleon Voted Company Of The Year At The OTC Marketing Awards 2022

Winners across 15 categories were announced at the OTC Marketing Awards 2022 on 28 November, with Haleon crowned OTC Company of the Year.

Ad Campaigns Launches

UK Pharmacies Recommending Short-Term Treatments Over PPIs For Frequent Heartburn – Haleon Survey

Haleon data shows a notable increase in UK pharmacy teams recommending PPIs for frequent heartburn in the year ended September 2022. However, pharmacies are still recommending alginate-based OTCs and antacids over PPIs for frequent heartburn in the majority of occasions, which Haleon says points to a need for more pharmacy education.

United Kingdom Health
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Latest From Ad Complaints & Health

On J&J Challenge, Review Finds Nothing Funny In Genexa’s ‘Real Ingredients’ Comparison To Tylenol

Genexa appeals NAD recommendations to stop using or modify claims that make up the core of its advertising to differentiate its products. NAD reviewed ad claims for Genexa kids’ Pain & Fever acetaminophen product on a challenge by J&J.

Ad Complaints Enforcement

Genexa Continues ‘Clean Medicine’ Mission With Guafenesin For Adults Launch

Launch comes six months after Genexa launched Acetaminophen Extra Strength and Acetaminophen PM caplets with “same active ingredients and dosages of current category leaders but without artificial dyes, synthetic fillers and other artificial preservatives,” and seven months after it was named to Fast Company’s annual list of the World’s Most Innovative Companies for 2022.

OTC Drugs Launches

Perrigo's Evidence For Nasal Spray Claims Not Enough For ASA

Ad claims that Perrigo’s BecoCleanse could protect against viruses to help prevent the occurrence of cold symptoms were not supported by sufficient evidence, the UK’s Advertising Standards Authority has ruled.

Ad Complaints OTC Devices
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