CVS, Walgreen suspend sales of brand and store brand ranitidine OTCs while Sanofi confirms it is not recalling Zantac in the US and has no plans to cease manufacturing or distributing.
CVS Health Corp. and Walgreen Co.aren’t waiting for the US Food and Drug Administration to complete its investigation of a potential carcinogenic contamination of ranitidine as the US drug store chains suspend sales of OTC Zantac and their store brand equivalents.
“The action is being taken out of an abundance of caution” that the H2 blocker products may contain a low...
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.”
Marking most strident use of authorities it received in 2020 as part of an overhaul of monograph system, FDA publishes proposal to shift orally disintegrating formats to individual-dose packaging and a related proposal to minimize firms’ regulatory burden for making delivery format changes potential
HELP members state frustration with layoffs at FDA and pose questions about topics from generic drug approvals to OTC switches, and from manufacturing location labeling to whether the federal agencies intrude on US consumers. Still, acting CDER director Jacqueline Corrigan-Curay makes clear the resu
