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Bullseye On OTC Reproductive Drug Approvals In US After Federal Judge Questions FDA Expertise?

 
• By Malcolm Spicer

Attorneys comment to HBW about likelihoods of litigation to challenge FDA’s approval of OTC emergency contraceptive and of influence growing to affect agency’s consideration of NDA for OTC daily oral contraceptive.

• Source: Shutterstock

A federal court ruling to stay the US Food and Drug Administration’s approval of abortion drug mifepristone likely will spur challenges to product approvals in categories across the agency’s oversight, with OTC emergency contraceptives potentially first on the list.

“I think if permitted to stand, the district court’s ruling could be destabilizing for drug development broadly,” said food and...

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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

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.

People On The Move: Appointments at BioGaia, Assosalute, Bayer

 
• By Tom Gallen

A round-up of the latest European people moves: BioGaia hires new subsidiary head from L'Oréal; Assosalute gets new director; Bayer renews contract of CEO.

Senate Bill Would Boost Oversight Of US FDA User Fee Program Following Trump Reorganization

 
• By Sarah Karlin-Smith

Senate appropriators also put FDA on notice regarding recent meetings and compliance with the Federal Advisory Committees Act, signal positive news on rare pediatric diseases, and offer hints of other agency areas they have close eyes on.