1. HBW Insight
  2. >>Health
  3. >>Rx-to-OTC Switch

For First US OTC Birth Control Application, FDA Extends Time For Advisory Panel Discussion

 
• By Lauren Nardella

After postponing planned November advisory committees’ meeting to have time to review more information it requested from sponsor HRA Pharma, FDA sets meeting for 9-10 May. Expanding meeting from one day to a day and a half should allow considering all views and questions about contraceptives.

• Source: Shutterstock

The US Food and Drug Administration’s extensions concerning a Perrigo Company PLC subsidiary’s OTC daily oral contraceptive application didn’t stop with needing additional time to review additional information it requested.

The agency has stretched an advisory panel meeting it will conduct to discuss the application from one day to 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
Start Free Trial

Already a subscriber?

More from Rx-to-OTC Switch

German Switch Committee Supports OTC Melatonin And Acyclovir, Rejects Rupatadine

 
• By David Ridley

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 Tom Gallen

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 David Ridley

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 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.

More from Health

Survey Suggests Target Market To Drive Opill Sales

 
• By Malcolm Spicer

Results of survey of 986 oral contraceptive users 15 to 45 years old published online in JAMA Network Open show OTC access drove a 31.8 percentage-point increase in women shifting from no contraceptive method to an effective method.

Youth Vaping Increases Likelihood Of Later Cigarette Use And Negative Health Impacts

 
• By David Ridley

Young people using e-cigarettes are about three times more likely than non users to initiate smoking and are more likely to suffer from a range of health issues, including asthma, mental health concerns, and drug use, according to a recently published umbrella review.

Kenvue Adds Vaping Cessation Indication To Nicorette QuickMist In Australia

 
• By David Ridley

Kenvue's Nicorette QuickMist becomes the first product in Australia to be approved by the Therapeutic Goods Administration (TGA) for the treatment of nicotine vaping dependence.