Drugs

Court Denies Ferring Prepopik Motion

The DC federal court has denied a Ferring Pharmaceuticals motion asking the court to enforce an earlier grant of summary judgment to Ferring that remanded to FDA the case of Ferring’s request for five-year exclusivity for its Prepopik colonoscopy preparation solution. The case revolves around a shifting determination of the chemical classification of a molecule in one of Prepopik’s active ingredients.

After FDA changed its classification determination and in the process denied Ferring the requested exclusivity, the company went back to the court claiming that the agency had not followed the court’s remand instructions to conduct proceedings in accordance with its approval of summary judgment for Ferring.

FDA argued that it had reexamined the question of whether picosulfate is the active moiety within sodium picosulfate in Prepopik and had come to a conclusion that the active moiety was actually bis-(p-hydroxyphenyl)-pyridyl-2-methane (BPHM), which is not eligible for new molecular entity exclusivity because it is in several other approved drugs.

The court held that the agency had not acted outside of its instructions because the question of whether picosulfate was the active ingredient had not been adjudicated as it was not needed to determine whether FDA had properly awarded exclusivity.

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