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Oxytrol For Women Gets OTC Green Light As Rare First-In-Class Switch

 
• By Dan Schiff

FDA approved Merck’s overactive bladder drug Oxytrol for Women for OTC use, despite concerns raised by the Nonprescription Drug Advisory Committee in November. The company plans a launch in the fall.

FDA approved Merck & Co. Inc.’s Rx-to-OTC switch application for overactive bladder drug Oxytrol for Women, marking the first successful first-in-class switch since alli for weight loss in 2007.

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More from Rx-to-OTC Switch

Over The Counter: Brands, Brexit And New Self-Care Business Models, With PAGB’s Michelle Riddalls

 
• By David Ridley

HBW Insight catches up with UK OTC industry association CEO Michelle Riddalls to talk about digital self-care and the unrealized promise of Brexit - part 2.

Preamble ‘Poison Pill’ Could Haunt ACNU Switch Rule – House Energy And Commerce Members

 
• By Malcolm Spicer

Reps. Latta, Crenshaw and Miller-Meeks contend language in ACNU final rule preamble would allow a sponsor of an approved application to litigate to halt Rx availability of same formulation and “risk eliminating the very rule on which its product approval was based.”

Over The Counter: Evolving The UK Consumer Health Industry, With PAGB’s Michelle Riddalls

 
• By David Ridley

HBW Insight catches up with PAGB CEO Michelle Riddalls to chat about the association's new five year plan. Riddalls also reflects on the successes of the last five years, including relaunching the UK Reclassification Alliance, which has published a list of Rx-to-OTC switches the government would like to see applications for. Part one of two.

Arkansas Law For OTC Ivermectin Sales Doesn’t Answer Dose, Format And Access Questions

 
• By Malcolm Spicer

“I’m not sure exactly if they understood how broad this actually is and what that might potentially lead to or what the follow-up would be if somebody now decides to sell a 10-milligram version of ivermectin for human use,” says food and drug regulation attorney Frederick Stearns.

More from Health

Plenty For Industry To Do As EU Wastewater Directive Faces Legal Challenges

 
• By David Ridley

Engaging with EU member state legislators, stressing the impact of national EPR systems on the accessibility, availability, and affordability of medicines, reformulating products to reduce their financial contribution, and lobbying for expanding the scope of EPR schemes to include other polluting industries are all ways that the European consumer health industry can try and influence the way that the revised Urban Wastewater Treatment Directive is transposed into national legislation, law firm Mason Hayes & Curran explains.

Futura Records First Profits And Targets Eroxon Extension

 
• By Tom Gallen

The US launch of Eroxon ED treatment by Haleon helped Futura Medical record its first ever profit in 2024. The UK firm will now look to capitalize this by seeking US and EU approval for a more potent Eroxon line extension.

Preamble ‘Poison Pill’ Could Haunt ACNU Switch Rule – House Energy And Commerce Members

 
• By Malcolm Spicer

Reps. Latta, Crenshaw and Miller-Meeks contend language in ACNU final rule preamble would allow a sponsor of an approved application to litigate to halt Rx availability of same formulation and “risk eliminating the very rule on which its product approval was based.”