Law360 (April 21, 2020, 5:12 PM EDT) — On April 1, the U.S. Food and Drug Administration initiated a market withdrawal request for ranitidine products (e.g., Zantac). This request comes on the heels of two important recent developments.
The first was the FDA’s November 2019 statement advising that “low levels” of the impurity N-nitrosodimenthylamine, or NDMA, which is classified by the International Agency for Research on Cancer as a probable human carcinogen, were detected in samples of ranitidine medications.
The second was the Feb. 6 Judicial Panel on Multidistrict Litigation order coordinating and consolidating pretrial proceedings against generic and branded ranitidine manufacturers under MDL 2924 in the U.S. District Court…
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