Drugs

CDER Explains MorphaBond Exclusivity

The CDER Exclusivity Board says that the scope of Daiichi Sankyo’sMorphaBond’s three-year exclusivity is labeling describing the expected reduction of abuse of single-entity extended-release morphine by the intranasal route of administration due to physiochemical properties. In a just-released determination, the board says the exclusivity expires 10/2/18.

MorphaBond (morphine sulfate), the document says, is the first FDA-approved, single-entity, morphine product with claims in the labeling related to deterring abuse via the intranasal and intravenous routes.

The board assessed the scope of MorphaBond’s exclusivity in light of a pending action for an application for another morphine sulfate extended-release tablet product with abuse deterrence claims in the proposed labeling. As part of its determination, the board recommended that the Orange Book be amended to describe the MorphaBond exclusivity code as “M-XXX, labeling describing the expected reduction of abuse of single-entity extended-release morphine by the intranasal route due to physiochemical properties.”

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