Drugs

FDA Denies US WorldMeds Apokyn Petition

FDA has denied without comment a 7/1 US WorldMeds petition asking that the agency:

require any ANDA referencing the company’s Apokyn (apomorphine hydrochloride) injection to seek approval of both the drug and medical device constituent parts of Apokyn; and
establish a policy framework clarifying the circumstances, if any, under which the drug constituent part of a generic drug-device combination product can be approved in an ANDA that does not also seek approval of the device constituent part.

Apokyn is supplied by US WorldMeds in a cartridge that is used with a manual reusable multiple-dose pen injector.

The FDA denial letter says the law requires the agency to take final action on the petition within 150 days of submission. Thus, since FDA has made no final determination on whether to approve or not approve any ANDA referencing Apokyn, it is denying the first request in the petition without comment. And since the second request would take FDA more than 150 days to evaluate and act on, it also is being denied without comment.

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