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GSK Proposes Adding OTC Oral Spray To US Smoking Cessation Sector

 
• By Malcolm Spicer

FDA schedules Nonprescription Drugs Advisory Committee meeting 18 September to consider GSK's NDA for an OTC nicotine oral spray that delivers 1mg per spray.

Smoking_Cessation

GlaxoSmithKline PLC's leading sales in the US OTC smoking cessation category could grow with its proposal for the first mouth spray product to be available Rx or nonprescription in the country.

The Food and Drug Administration has scheduled a Nonprescription Drugs Advisory Committee meeting for 18 September to consider GlaxoSmithKline Consumer...

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More from Europe

Haleon Study: Self-Care Policies Could Save Finland €60m Per Year

 
• By David Ridley

Creating a working group to drive Rx-to-OTC switch is one of the ways in which Finland could expand self-care and save €60m per year for the country's health system, suggests a recently published report commissioned by Haleon.

PAGB: UK Gov Must Invest In Self-Care To Realize ‘Untapped Potential’

 
• By David Ridley

Reacting to chancellor Rachel Reeves' 2025 public spending review, PAGB welcomed increased funding for healthcare and life sciences while stressing the need to promote self-care practices.

German Associations Call For EU Green Claims Directive Trilogue Suspension

 
• By David Ridley

Pharma Deutschland is one of 21 German associations calling for trilogue negotiations in relation to the EU Green Claims Directive to be suspended while a “comprehensive and independent written impact assessment” is undertaken.

Over The Counter: EU Omnibus And ESG, What You Need To Know, With CEN Group’s Jasper Crone

 
• By David Ridley

HBW Insight catches up with sustainability expert Jasper Crone to find out what consumer health companies need to know about the European Commission's Omnibus simplification package.

More from Geography

AESGP Annual Meeting: European OTC Market Outlook ‘Very Positive’ Thanks To Prevention Trend

 
• By David Ridley

The European OTC market grew at double the rate of the global market in the last twelve months, according to IQVIA Consumer Health, driven by a long-term trend for prevention. Consultancy Simon Kucher identifies a desire to live a longer, healthier life as the primary concern behind this trend.

AESGP Annual Meeting: Harmonizing EU VMS Max Levels Could Cost Sector Over €200m

 
• By David Ridley

Limited capacity and a two-to-three year timescale for reformulation could mean that many VMS supplements disappear from the market, warns EPPA partner Alexandra Bocquillion, speaking at the AESGP Annual Meeting in Warsaw, Poland.

EU Pharma Reform: Council Proposes Rx Exemption For Topical Antimicrobials

 
• By David Ridley

The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”