Fortacin Wins Commission Approval As Fifth EU-Wide Rx-To-OTC Switch

European Commission approval of Fortacin as OTC premature ejaculation treatment makes it only the fifth drug switched EU-wide through the centralized procedure. 

Red Approved Stamp with Wooden handle Rubber Stamper Isolated on White Background.
• Source: Shutterstock

Recordati SpA has cleared the final hurdle to reclassifying premature ejaculation treatment Fortacin from prescription-to-OTC status across the EU after the European Commission approved the switch.

More from Rx-to-OTC Switch

AESGP: ‘No Evidence’ Of Antimicrobial Resistance With OTC Antifungals Or Antivirals

 
• By 

Two AESGP papers reviewing the evidence for AMR risk associated with a range of OTC antifungals and antivirals conclude there is litte to no risk associated with the responsible self-care use of such medicines.

Over The Counter: What To Expect From The 61st AESGP Annual Meeting, With Jurate Švarcaite

 
• By 

HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.

‘Nothing Unexpected’ In Third Failed Application For OTC Sildenafil In Germany

 
• By 

“Overall, no unexpected/new data or findings” were presented to Germany's Expert Committee for Prescription in the most recent Rx-to-OTC switch application for sildenafil (25mg and 50mg), according to medicines regulator BfArM, resulting in a third rejection in three years.

Over The Counter: Women’s Health Innovation And Beyond, With Maxwellia’s Anna Maxwell

 
• By 

HBW Insight catches up with Maxwellia CEO Anna Maxwell to discuss her company's journey so far, and what she sees as the opportunities for Rx-to-OTC switch in UK women's health and beyond.

More from Health

People On The Move: Appointments At PAGB, Activ’Inside, EMA

 
• By 

Round up of the latest appointments: PAGB names vice presidents; Activ'Inside gets first US head; EMA elects management board chair.

Over The Counter: What To Expect From The 61st AESGP Annual Meeting, With Jurate Švarcaite

 
• By 

HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.

Longer ACNU Rule Review Gets Kennedy Signature

 

Notice published on 21 March is a word-for-word copy, other than different dates, of a document published on 24 January, Kennedy says the ACNU final rule’s effective date is delayed until 27 May, two months later than the initial delayed effective date.