Worries about N-nitrosodimethylamine, a suspected carcinogen which has been found in the popular heartburn drug ranitidine, has led to an expansion of recalls and halts to distribution by companies worldwide.
More Recalls Seen For Ranitidine
Sandoz is voluntarily recalling all ranitidine hydrochloride capsules in the US because of “confirmed’ NDMA contamination, while Dr Reddy’s is suspending global shipments of the generic version of Zantac due to worries about the presence of the suspected cancer-causing agent in its products, as suppliers around the world grapple with the issue.
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In the wake of a report marking 10 years since the first US biosimilar launch, Cardinal Health’s Dracey Poore speaks to Generics Bulletin about the successes seen so far and the obstacles that must be overcome if the market is to thrive in the decade ahead.
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Generics Bulletin reviews global regulatory developments across the world.
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The US Senate Judiciary Committee’s Chairman Chuck Grassley criticized the Senate’s reduced working hours as six previously introduced bills once again land on their desk.
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Henlius has reported progress in its development of a bevacizumab product for treating ophthalmic diseases, with its Essex-partnered HLX04-O candidate meeting its primary endpoint in a Phase III trial. Meanwhile, Outlook Therapeutics has taken another shot at getting its own ophthalmic bevacizumab approved in the US after resubmitting its filing.
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Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.
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Henlius has reported progress in its development of a bevacizumab product for treating ophthalmic diseases, with its Essex-partnered HLX04-O candidate meeting its primary endpoint in a Phase III trial. Meanwhile, Outlook Therapeutics has taken another shot at getting its own ophthalmic bevacizumab approved in the US after resubmitting its filing.
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While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.