Drugs

Commerce Committee Asks FDA How to Expedite EpiPen Generics

House Energy and Commerce Committee leaders have written FDA asking for details on what the agency can do to expedite generic copies of Mylan’s EpiPen Auto-Injector (epinephrine injection) amid growing criticism of cost increases related to the product. The letter asks FDA to provide details on how many epinephrine injection ANDAs have been submitted, rejected and are pending. Also, it asks whether the agency has made processing such ANDAs a priority. Additionally, it asks whether ANDAs need to use identical drug delivery technology as the reference-listed product, and the types of design differences would be acceptable.

Meanwhile, Mylan now says it will launch an authorized generic of the product that will be discounted 50% of the branded product’s list price (see story). “The authorized generic will be identical to the branded product, including device functionality and drug formulation,” the company says, adding that it will be on the market in the next several weeks.

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