Drugs

Complete Response Sent to Egalet On New Pain Drug Doses

FDA has issued Egalet Corp. a complete response letter on a prior approval supplement (PAS) for Oxaydo (oxycodone HCl, USP) tablets [Schedule C-II] in 10 mg and 15 mg dosage strengths. The agency letter requested more information about the effect of food on Oxaydo 15 mg and the intranasal abuse-deterrent properties of Oxaydo 10 mg and 15 mg, the company says. Egalet adds that it will work with FDA to determine the path forward.

The company submitted the PAS earlier this year, seeking to market the strengths for use in treating moderate to severe pain. The submission was based on a pharmacokinetic study demonstrating bioequivalence of Oxaydo to its reference drug, Roxicodone at the 15 mg dosage strength, according to the company.

Oxaydo, which was originally approved 12/2015 in 5 mg and 7.5 mg dosage strengths, is designed to discourage intranasal abuse. It uses a patent-protected formulation that contains an inactive ingredient that may cause nasal burning if manipulated and snorted.

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

Read more

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