Drugs

Torrent Pharma Expands Losartan Recall

Torrent Pharmaceuticals has expanded its recall from 10 lots of losartan potassium tablets to include six lots of losartan potassium and hydrochlorothiazide tablets due to the detection a suspected carcinogenic impurity, N-nitrosodiethylamine (NDEA) in an active pharmaceutical ingredient manufactured by Hetero Labs Limited. NDEA occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen the international Agency for Research on Cancer. According to an updated recall notice, Torrent is only recalling lots that contain NDEA above the acceptable daily intake levels characterized by FDA. Losartan is used to treat hypertension, hypertensive patients with left ventricular hypertrophy and nephropathy in Type 2 diabetes patients.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome