Advisory Panel Members On Unanimous Vote Recommending US FDA Approve OTC Birth Control

NDAC and ORUDAC members acknowledged the FDA’s concerns about some data provided by Opill sponsor HRA Pharma to support its OTC switch application. However, a greater share noted the “historic nature” of the proposal and the broad support expressed in the meeting’s public comment portion.

• Source: Shutterstock

Members of a US Food and Drug Administration advisory panel, to a person, concluded that the potential benefits of OTC sales of a daily oral contraceptive outweigh the risks.

Several agreed with FDA concerns about some data the sponsor of the application for the OTC switch provided, but a...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Rx-to-OTC Switch

German Switch Committee Supports OTC Melatonin And Acyclovir, Rejects Rupatadine

 
• By 

Germany’s Expert Committee for Prescription supports the Rx-to-OTC switches of melatonin and buccal acyclovir but rejects rupatadine.

Navamedic To Market OTC Naloxone In Norway Following Switch

 
• By 

Navamedic adds Ventizolve to its portfolio shortly after Norway switched the opioid overdose reversal drug from Rx to OTC.

Viatris Switches Innovative Dual Action Nasal Spray In The UK

 
• By 

Now available without a prescription, Dymista Control is the first OTC combination treatment for consumers who are struggling to control their seasonal allergic rhinitis with a corticosteroid or antihistamine nasal spray, according to the firm.

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

 
• By 

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.

More from Health

Navamedic To Market OTC Naloxone In Norway Following Switch

 
• By 

Navamedic adds Ventizolve to its portfolio shortly after Norway switched the opioid overdose reversal drug from Rx to OTC.

Green Regulation Is ‘A Baseline Not A Burden’ – Behind Opella’s B Corp Journey

 
• By 

“For us, regulation is the floor, not the ceiling,” Opella's chief sustainability officer Marissa Saretsky tells HBW Insight as the firm gains B Corp Certification. Other topics covered in this exclusive interview include Opella's position on the revised Urban Wastewater Treatment Directive.

FDA Warns Whoop BPI App Is Unauthorized Device; Firm Says Wearable Is A Wellness Tool

 

Recent FDA warning letter claims Boston firm specializing in wearable technology marketed a blood pressure device without agency approval, but the company rejects the assertion and says the agency is out of step with federal regulations.