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Novel Non-Stimulant Weight Management Aid Cleared by FDA

Gelesis announced that the Food and Drug Administration (FDA) has cleared Plenity (Gelesis100) to aid in weight management for overweight and obese adults, in conjunction with diet and exercise. Available in capsule form, Plenity, a non-systemic, superabsorbent hydrogel, is intended for use in adults with a body mass index (BMI) of 25–40kg/m2 and is taken…

Manufacturing Processes Contributed to Impurities in ARB Meds, Says FDA

In the summer of 2018, the FDA learned that some generic ARB medications, including valsartan, irbesartan, losartan and others contained nitrosamine impurities— including N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA)—posing a potential safety concern.