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OTC Daily Oral Contraceptive Proposal In US Packs Promise Of Access, But Peril Of Single Option

 
• By Malcolm Spicer

Discussion of whether progestin-only formulation will be approved for OTC sales and succeed in the US nonprescription market perhaps has been overshadowed by expectations of political pressures affecting FDA’s evaluation and decision after HRA submitted its NDA.

• Source: Shutterstock

Discussion emerged soon after a proposal for the first OTC daily oral contraceptive in the US was announced on whether approval would swing on influences other than the drug’s safety and efficacy for use without the intervention of a medical professional.

Prevalent in the discussion are mentions of HRA Pharma’s new drug application for OTC 0

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New Zealand Could Become First Country To Offer Gout Drug Allopurinol OTC

 
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At the second attempt, New Zealand’s Medicines Classification Committee supported the Rx-to-OTC switch of allopurinol (100mg and 300mg) for people suffering from gout by specifically trained pharmacists.

Over The Counter: Everything You Wanted To Know About Real World Evidence, With IQVIA’s Volker Spitzer

 
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HBW Insight finds out all about real world evidence and its potential for the OTC industry by chatting with IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer.

Trump Order To Improve Making More Drugs Available OTC Puts Wind Behind Petros’ ACNU Sails

 
• By Malcolm Spicer

Petros will incorporate into its platform an analytics firm’s automated document capture and authentication system leveraging its global ID library to verify identity and eligibility of consumers accessing the self-selection process for an ACNU switch.

Melatonin And Buccal Acyclovir On German Switch Committee Agenda

 
• By David Ridley

An application for melatonin as an OTC medicine is on the agenda for the next German switch committee meeting, despite the hormone being widely available in food supplements. Acyclovir as a buccal tablet and second-generation antihistamine rupatadine are also up for discussion.

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New Zealand Could Become First Country To Offer Gout Drug Allopurinol OTC

 
• By David Ridley

At the second attempt, New Zealand’s Medicines Classification Committee supported the Rx-to-OTC switch of allopurinol (100mg and 300mg) for people suffering from gout by specifically trained pharmacists.

Mitigating Tariff Impacts, Kenvue Adjusts Outlook

 
• By Malcolm Spicer

“The situation has evolved considerably” since Kenvue gave its initial full-year outlook in February, “and remains quite fluid,” says president and CEO Thibaut Mongon as firm reports Q1 net sales decreasing 3.9% to $3.7bn

Looming Tariffs Give Boost To Latest PCH Results While Cutting Costs In Response Takes Priority

 
• By Malcolm Spicer

Looming imposition of tariffs by Trump on imports from most every country had an influence on consumers during the January-March period, particularly on online shopping. Increasing product prices on the table, “but our efforts are going to start with cost savings,” says CFO Christine Sacco.