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US FDA Requests Ranitidine Removal But Also Encourages Research For Stable Formulations

 
• By Eileen Francis

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.

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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.

After testing found levels of the probable carcinogen N-nitrosodimethylamine (NDMA) increases in ranitidine over time in storage, especially at higher...

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EU Pharma Reform: Council Proposes Rx Exemption For Topical Antimicrobials

 
• By David Ridley

The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”

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• By Malcolm Spicer

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