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A group of consumers filed a class action suit against Pfizer, alleging that the company knew or should have known that its over-the-counter heartburn drug Zantac (ranitidine) was contaminated with dangerous levels of NDMA and unsafe for consumption. Read More
Allergan reached a $300 million settlement to resolve a class action lawsuit over the oral contraceptives Loestrin 24 Fe (norethindrone acetate, ethinyl estradiol, and ferrous fumarate) and Minastrin 24 Fe (norethindrone acetate and ethinyl estradiol/ferrous fumarate). Read More
CDER Director Janet Woodcock flagged 2019 as a strong year for novel drug approvals, although the total dipped to 48 from the ten-year record of 59 for 2018. Read More
Ranitidine can generate N-nitrosodimethylamine (NDMA) when stored at higher temperatures, a research laboratory has found, raising new safety concerns. Read More