Concerned By Confusion Over OTC Drug Brands, US FDA Offers Guidance On Developing Names

Extending an OTC brand name to a product with a different active ingredient and indication creates a margin for error in the marketplace, FDA says. Recommendations include best practices to help minimize name-related medication errors and a framework FDA uses in evaluating proposed propriety names.

Post-market surveillance of medication errors showing that consumers confuse nonprescription drug brands with Rx drugs has prompted a draft guidance from the US Food and Drug Administration on developing OTC brand names.

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Pharma Exhales, Dodges Financial Blow With Tariff Exemption

 

Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.

Eisai Switches Proton Pump Inhibitor Rabeprazole To OTC In Japan

 
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Eisai aims to support people in Japan with severe heartburn and discomfort caused by gastric acid related conditions by switching from prescription to OTC status its Pariet-branded proton pump inhibitor.

German Industry Urges ECHA To Reconsider ‘De Facto’ EU Ethanol Ban

 
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Reclassifying ethanol as a carcinogenic, mutagenic, or reprotoxic substance - something the European Chemicals Agency seems likely to do in the near future - would be “tantamount to a de facto ban” with “fatal consequences” for medical care in Germany, says Pharma Deutschland in a joint paper with 13 other German healthcare industry associations.

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

 
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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.

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Democrats Torch Trump’s HHS Layoffs During House Hearing On OMUFA Reauthorization

 

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German Industry Urges ECHA To Reconsider ‘De Facto’ EU Ethanol Ban

 
• By 

Reclassifying ethanol as a carcinogenic, mutagenic, or reprotoxic substance - something the European Chemicals Agency seems likely to do in the near future - would be “tantamount to a de facto ban” with “fatal consequences” for medical care in Germany, says Pharma Deutschland in a joint paper with 13 other German healthcare industry associations.

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.