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EU Suspends Ranitidine Medicines

 
• By Neena Brizmohun

In addition to deciding to suspend ranitidine-containing medicines, the European Medicines Agency has issued recommendations on testing patients for DPD deficiency before they are treated with fluorouracil or related medicines.

Reflux_Acid
EU regulators have now reviewed the safety of heartburn drug ranitidine • Source: Shutterstock

Ranitidine medicines are being suspended in the EU due to the presence of the nitrosamine impurity, N-nitrosodimethylamine (NDMA).

While a review of safety data by the European Medicines Agency does not show that ranitidine increases the risk of...

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More from Regulation

Sandoz Scores Regional First With EU Launch Of Autoinjectable Stelara Rival

 
• By Adam Zamecnik

Doubling down on the launch of its Stelara biosimilar Pyzchiva in Europe last year, Sandoz has just released an autoinjectable version of the drug, with the aim to offer a more convenient option for ustekinumab patients.

Sun On Leqselvi US Launch Ahead, MFN Pricing And Pipeline Changes

 
• By Anju Ghangurde

Sun readies US debut of Leqselvi for alopecia areata, while PD-L1 inhibitor Unloxcyt is in the line up once the Checkpoint Therapeutics deal is completed. Management also discusses limited clarity on President Trump’s most favored nation pricing push, pipeline tweaks and M&A outlook.

Trump-Trimmed FDA Finally Releases A Batch Of PSGs – Back To Business As Usual?

 
• By Urtė Fultinavičiūtė

After half a year of silence, the US FDA has published 48 product-specific guidances for generic development. With critical staff laid off, will the health agency stick to its updated PSG publishing schedule?

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.

More from Policy & Regulation

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.

Fresenius Adds To Denosumab Competitors In Europe

 
• By Dave Wallace

At a busy meeting of the CHMP, the EMA issued positive opinions for Fresenius Kabi’s denosumab rivals to Prolia and Xgeva, another denosumab biosimilar from Sandoz, a Tecfidera hybrid from Neuraxpharm and a Descovy generic from Viatris. Meanwhile, Ascend has withdrawn a teriparatide filing.

Regulatory Recap: ICH To Determine The Future Of Biosimilar Comparative Efficacy Studies

 
• By Urtė Fultinavičiūtė

Generics Bulletin reviews global regulatory developments across the world.