Drugs

Endo Wants Generic Epinephrine Restrictions

Endo is petitioning FDA to impose restrictions on 505(b)(2) and 505(j) applications for pharmaceutical equivalents of specific ready-to-use concentrations of intravenous epinephrine covered by an Endo NDA that FDA approved on 4/21/2023. The company’s 2/12 petition specifically asks FDA to:

refrain from receiving for filing or approving any 505(b)(2) application that was filed after 4/21/2023, covers at least one product that is pharmaceutically equivalent to at least one product covered by the Endo NDA and does not reference the Endo NDA;
refrain from receiving for filing or approving any 505(j) application that was filed after 4/21/2023, covers at least one product that is pharmaceutically equivalent to at least one product covered by the Endo NDA and does not reference the Endo NDA; and
deny any petition that seeks a change previously approved in Endo’s NDA and which product does not reference Endo’s NDA.

The petition concludes that “FDA’s clear regulations and long-held policies demonstrate that an ANDA or 505(b)(2) application must reference the NDA of a previously approved pharmaceutical equivalent.”

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