Drugs

Narcan Petition Approved in Part

FDA has granted in part and denied in part an Adapt Pharma Operations 11/23/16 petition asking that the agency not approve any ANDA referencing Adapt’s Narcan (naloxone hydrochloride) nasal spray that does not provide specific pharmacokinetic, device, stability, and chemistry, manufacturing, and controls data.

FDA’s response letter says the agency agreed that a product-specific guidance for naloxone nasal spray would be helpful to applicants developing generic intranasal naloxone products and issued such a guidance concurrent with the petition response. The draft guidance recommends two different approaches for demonstrating bioequivalence, the letter says, and includes information on the device component of a proposed generic. Thus, the company’s request for a product-specific guidance is granted.

Another element of the Adapt request was granted to the extent that the draft guidance includes recommendations about pharmacokinetic testing at early time points. But the request to include specific partial AUC time points was denied.

FDA did not accept an Adapt request that human factor studies be required. And a request that generic manufacturers be required to include a minimum of two doses per pack was also denied.

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