The US Food and Drug Administration requested immediate removal of ranitidine-containing drugs from the market while also encouraging the industry to make the products more stable because the ingredient remains approved for use in the US.
US FDA Requests Ranitidine Removal But Also Encourages Research For Stable Formulations
FDA requests immediate removal of ranitidine OTC and Rx drugs after third-party testing finds contaminant NDMA increases during storage, especially at higher temperatures. CDER Director Janet Woodcock asks firms to reformulate products to be stable as the ingredient remains approved.
More from Regulation
• By
HBW Insight catches up with PAGB CEO Michelle Riddalls to chat about the association's new five year plan. Riddalls also reflects on the successes of the last five years, including relaunching the UK Reclassification Alliance, which has published a list of Rx-to-OTC switches the government would like to see applications for. Part one of two.
• By
Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.
• By
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.
• 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.
More from Policy & Regulation
• By
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.
• By
A round-up of the latest industry moves in Europe: Pharma Deutschland elects board of new Brussels operation; MHRA's new CEO gets to work; Futura names non-executive director.
• By
“If this doesn’t get reauthorized, look at the number of the ingredients out there, the number of products, what would happen all those products out there for the consumer, on that shelf, in the drugstore or someplace?” says Rep. Bob Latta during House hearing.