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First OTC Birth Control Pill Approved In US Will Launch With Three-Year Market Exclusivity

 
• By Malcolm Spicer

FDA approval of Perrigo subsidiary HRA’s application comes 60 years after Rx birth control was approved in the US, one year after the application was submitted, and 13 months after the Supreme Court’s Dobbs ruling. Perrigo plans to launch sales in 2024 first quarter.

• Source: Shutterstock/HBW Insight

Perrigo Company PLC has launched an OTC switch before, but its first with three-year market exclusivity will be Opill, approved as the first nonprescription daily oral contraceptive available in the US.

The Food and Drug Administration's approval announced on 13 July of Perrigo subsidiary HRA Pharma’s supplemental new drug application, 60...

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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

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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.

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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

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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.