Drugs

Lawmakers Ask FDA to Weigh in on EpiPen Alternatives

With the huge outcry from media, parents and healthcare professionals on Mylan increasing its EpiPen (epinephrine injection) auto-injector by 400%, lawmakers have written FDA asking what it can do to ensure approval of competitive alternatives. “We are concerned that Mylan has not faced much competition for its product,” the lawmakers say in their letter. “One of its competitors, Auvi-Q, was recalled in October 2015, giving Mylan a near monopoly with its product.

“News reports indicate that generic versions of the EpiPen have been subject to additional questioning by the FDA and have yet to be approved. We have always championed access to safe, efficacious, and affordable medications. It would be helpful if the FDA could clarify whether any barriers exist to the approval of safe alternative products to the EpiPen.” The letter also asked FDA to explain the steps it has taken to “ensure an efficient and safe approval process for competitive alternatives to the EpiPen is not hampered by backlogs.”

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