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Fly News Breaks for July 13, 2018
Jul 13, 2018 | 12:08 EDT
Evercore ISI analyst Umer Raffat notes that the FDA website shows that a generic version of Valeant's (VRX) Apriso, a top 10 product for the company, has been granted a tentative approval. This approval, which was granted to Teva (TEVA), is the second generic approval for one of the company's top 10 products in the last few days, as a generic Uceris approval was also recently granted, added Raffat in his note to investors. He maintains an In Line rating on Valeant shares.
News For VRX;TEVA From the Last 2 Days
Sep 13, 2019 | 09:55 EDT
The Food and Drug Administration has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine at low levels, the agency said in a statement. Zantac is marketed by Chattem, a Sanofi company. NDMA is classified as a probable human carcinogen, or a substance that could cause cancer, based on results from laboratory tests, the FDA added. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables, it adds. The FDA said, "The agency is working with international regulators and industry partners to determine the source of this impurity in ranitidine. The agency is examining levels of NDMA in ranitidine and evaluating any possible risk to patients. The FDA will take appropriate measures based on the results of the ongoing investigation. The agency will provide more information as it becomes available." The European Medicines Agency also announced this morning in investigation into some ranitidine medicines. Reference Link