Drugs

FDA Warns India Pharmacy Over Unapproved Drugs

FDA says it has determined that Champaklal Maganlal Homeo Pharmacy Private Limited in Gujarat, India, is manufacturing, importing, or distributing two unapproved drugs through CAD Import and Pharmadel, both in New Castle, DE. A 5/18 Warning Letter says the firm’s Bebelyn Diarrhea and Bebelyn Colic are particularly concerning from a public health perspective because of current good manufacturing practice regulation violations cited in a 4/10 Warning Letter to Champaklal Maganlal and because the products are directed for use in infants and young children.

The letter says FDA recognizes that the two products are labeled as homeopathic drugs with active ingredients measured in homeopathic strengths. It reminds the company that homeopathic products are subject to the same statutory requirements as other drugs.

The firm was told to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of the actions and a schedule for completing the corrections.

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