Drugs

KemPharm Wins User Fee Waiver for Pain Drug

FDA has granted KemPharm a user fee waiver and refunded the $2.4 million fee it paid when submitting an NDA for KP201/APAP, an investigational immediate-release combination of its hydrocodone prodrug, KP201 (benzhydrocodone hydrochloride), and acetaminophen (APAP). The submission was given a priority review and a 6/9 review target date. Under agency regulations, a fee waiver can be granted to a small business for the first human drug application submitted to the agency for review.

KemPharm developed the product using its proprietary “Ligand-Activated Technology,” which it says creates a new prodrug by chemically attaching one or more molecules, or ligands, to an FDA-approved parent drug. “Once administered, human metabolic processes, such as those in the gastrointestinal tract, separate the ligand from the prodrug and release the active parent drug, which can then provide its therapeutic effect,” it says.

The company believes that prodrugs “developed using our Ligand-Activated Therapy technology may demonstrate properties that are aligned with the advice of regulatory, physician and patient organizations advocating for responsible measures for managing pain and prescribing opioids, including recommendations that opioid therapy for chronic pain begin with the introduction of immediate-release opioids as a means to reduce the risks associated with long-acting or extended-release opioids.”

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