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Petros Includes Nitrate Patients In OTC ED Drug Self-Selection Studies

 
• By Malcolm Spicer

Firms also notes in its announcement that FDA typically requires actual use trials for switch NDAs in addition to label comprehension studies, which it has conducted, and self-selection studies.

• Source: Alamy

Self-selection studies starting for Petros Pharmaceuticals Inc.’s erectile dysfunction drug Stendra (avanafil), one with men also using nitrate medicines, could be pivotal to the US Food and Drug Administration’s potential reception for the firm’s planned OTC switch proposal.

“This is an important next step in the development plan to seek non-prescription status for Stendra and will inform whether...

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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

People On The Move: Appointments At Enzymatica, Haleon, Futura

 
• By Tom Gallen

A round up of the latest moves in Europe's consumer health market: Enzymatica appoints CEO; Haleon hires DACH marketing chief; Futura confirms interim CEO.

Industry Pleased To See Self-Care In Revised English Children’s Education Policy

 
• By David Ridley

Children and young adults will in future learn more about responsible self-care, including when it is appropriate to see a pharmacist, specific instructions for dental health and information about health risks associated with smoking, vaping, and other nicotine products such as nicotine pouches.

Primatene Mist Sales Flat As Amphastar Plans Production Expansion To Support Pipeline

 
• By Malcolm Spicer

Amphastar plans three- to five-year expansion to quadruple production capacity for its US manufacturing operations at its Rancho Cucamonga, CA, headquarters. Primatene Mist Q2 sales reached $22.88m from $22.86m a year ago.