Drugs

FDA Complete Response Letter on Teva Generic EpiPen

FDA has issued Teva a complete response letter on its epinephrine ANDA, a generic copy of Mylan’s EpiPen, indicated for emergency treatment of allergic reactions, including potentially fatal anaphylaxis. Teva says the agency cited “certain major deficiencies,” and it intends to submit a response. The company says it expects that its epinephrine product will be significantly delayed and that any launch will not take place before 2017.

The delay is a boost to Mylan and EpiPen’s $1 billion in annual sales. Last year, Mylan lost a bid to delay Teva’s ANDA when FDA denied a petition that questioned the sameness of the Teva product. Mylan’s petition had argued that patients, caregivers, and other relevant user groups trained in the use of the EpiPen auto-injector who face an emergency situation would not be able to safely and effectively use Teva’s proposed product in accordance with the EpiPen instructions for use, without additional physician interaction or training. FDA’s denial letter said it has made no final determination on whether to approve or not approve any ANDA relying on the EpiPen as a reference-listed drug. Therefore, FDA said, it does not interpret its regulations as requiring it to provide a final agency decision on the “approvability of a specific aspect of an application when a final decision on the approvability of any such application has not yet been made.”

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