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Opill Proposal Makes ACNU Sense, Stakeholders Comment On US 'Additional Conditions' Proposal

 
• By Lauren Nardella

As pharma marketing and Rx-to-OTC switch experts told HBW Insight, health care industry stakeholders submitting comments to the FDA connect Opill NDA to FDA’s consideration of an ACNU pathway.

• Source: Shutterstock

A potential overlap between the first OTC daily oral contraceptive proposed in the US and the “additional conditions for nonprescription use” the Food and Drug Administration is considering for OTC approvals is noted in comments to the agency on each of the topics.

The FDA hasn’t referenced the other topic in all of its notices and announcements about either Perrigo Company plc business HRA Pharma’s new drug application to make 0

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More from Rx-to-OTC Switch

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.

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

 
• By David Ridley

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.

More from Health

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.

Global Alliance Urges UN General Assembly To Put Self-Care At Centre Of NCD Strategy

 
• By David Ridley

Including self-care in an upcoming UN General Assembly political declaration would be a “powerful signal that the global community is serious about non-communicable disease prevention and control,” argues the United for Self-Care Coalition, which includes the Global Self-Care Federation, International Self-Care Foundation and Imperial College London’s Self-Care Academic Research Unit.