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GlaxoSmithKline lost its bid to end multiple lawsuits against the company alleging that its anti-nausea drug Zofran (ondansetron) caused birth defects. Read More
Online pharmacy Valisure petitioned the FDA to recall and suspend the sale of all ranitidine-containing products in the U.S., claiming it found high levels of NDMA across multiple manufacturers and dosage forms. Read More
Walgreens and Rite Aid joined CVS in suspending sales of ranitidine products amid concerns over contamination of the heartburn drugs with a probable carcinogen, N-nitrosodimethylamine (NDMA). Read More
Dr. Reddy’s has become the latest company to halt worldwide sales of the heartburn medication ranitidine as multiple regulatory authorities continue to investigate reports of the probable carcinogen, NDMA, in the products. Read More
An online pharmacy petitioned the FDA to recall and suspend the sale of all ranitidine-containing products in the U.S., raising alarms after its tests of the drug detected high levels of NDMA impurities across multiple manufacturers and dosage forms. Read More
CDER Director Janet Woodcock said Wednesday that the agency believes the risks posed to patients by nitrosomine impurities in blood pressure drugs are “likely much lower” than initially thought. Read More
Acting FDA Commissioner Ned Sharpless flagged “significant quality and sterility concerns” surrounding a Melbourne, Florida outsourcing facility on Tuesday, as the agency sought a recall of all sterile products compounded at the facility. Read More
“Women able to have children must have a pregnancy test before starting treatment with Gilenya to ensure they are not pregnant, and must use effective contraception during treatment and for two months after stopping the medicine,” the EMA advised. Read More
The FDA has approved new warnings for Xeljanz and Xeljanz XR (tofacitinib), including a boxed warning. The warning of an increased risk of blood clots and death applies to the 10 mg twice daily dosage of the drug, which is approved for certain patients with ulcerative colitis. Read More
“It’s clear more needs to be done to better ensure the safe use of these medicines, mitigate their risks and assure appropriate prescribing,” Gottlieb said. Read More
FDA Commissioner Scott Gottlieb on Wednesday announced new steps the agency is taking to tighten safety requirements for transmucosal immediate-release fentanyl (TIRF) products. Read More