to the potential for dangerous levels of NDMA to develop in ranitidine. While the FDA investigated, voluntary recalls removed most over-the-counter ranitidine products from the market, but it was still available by prescription.
“We’re saying they aren’t defective but could become defective stored under stressful conditions for the product,” Woodcock said during the briefing. “I can’t recall anything exactly like this happening before.”David Light, CEO of Valisure, is glad ranitidine is being removed from the market, but he doesn’t believe the problem has been solved completely. “The FDA was originally focused on manufacturing, which I can understand,” he said.
The approvals process itself may change after this discovery. “This needs to be institutionalized and put into the ordinary testing of pharmaceuticals, so we don’t find out once they’re on the market that there’s a problem,” she said. Woodcock expects the FDA to be putting out guidance for the industry in the near future.
We have summarized this news so that you can read it quickly. If you are interested in the news, you can read the full text here. Read more:
Nigeria Nigeria Latest News, Nigeria Nigeria Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
FDA Says Zantac Should Be Pulled From Market, Citing Cancer RiskMajor pharmacies had already pulled the popular heartburn drug and its generic equivalents due to a contaminant. Now the Food and Drug Administration says definitively they should not be sold or used. Oh, now EVIL $ FDA $ WANTS TO PULL POISON ZANTAC, MILLIONS HAVE CANCER NOW$$$$$$$$$$$$$$$$$ They did that last year. Have you or a loved one taken medication like Zantac, and experienced abdominal pain or stomach or other cancers? You could be entitled to compensation. Call Utah's Robert DeBry and Associates right now at 801-699-9999 or online at zantac zantacrecall
Source: NPR - 🏆 96. / 63 Read more »
FDA Orders Zantac, Similar Heartburn Medicines Off the MarketThe FDA ordered that the popular heartburn drug Zantac and other ranitidine generics be pulled from the market immediately, saying levels of a possible cancer-causing chemical found last year in some ranitidine products increases over time Dang ive taken these smh Bullshit....FDA wants to sell newer drugs at high price....US FDA hates Americans. darshanvmehta1 pls adv what are the contributions on these products to topline ... any impact on India operations !!
Source: WSJ - 🏆 98. / 63 Read more »