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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 changes or additional labelling may be necessary to guide appropriate use and to help

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Trump Order To Improve Making More Drugs Available OTC Puts Wind Behind Petros’ ACNU Sails

 
• By Malcolm Spicer

Petros will incorporate into its platform an analytics firm’s automated document capture and authentication system leveraging its global ID library to verify identity and eligibility of consumers accessing the self-selection process for an ACNU switch.

Melatonin And Buccal Acyclovir On German Switch Committee Agenda

 
• By David Ridley

An application for melatonin as an OTC medicine is on the agenda for the next German switch committee meeting, despite the hormone being widely available in food supplements. Acyclovir as a buccal tablet and second-generation antihistamine rupatadine are also up for discussion.

Access To Discounted Naloxone In California Expanded To All Consumers With Potential Need

 
• By Adam Zamecnik

After the product’s initial launch in May 2024, California’s government has now expanded the availability of its CalRx-branded generic OTC Narcan to all of its citizens.

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