Drugs

FDA Again Reviews Remoxy NDA for Pain Relief

FDA has accepted for review a Pain Therapeutics NDA resubmission for Remoxy ER (oxycodone capsules), indicated for treating severe pain. The agency has set a user fee review action target date of 8/7.

The drug has a long history at FDA, having been rejected on three previous submissions. The most recent was in 2016 when FDA sent a complete response letter that asked for “additional actions and data” before considering approval again. The letter focused on the drug’s abuse-deterrent properties and proposed drug labeling, according to the company, adding that it did not question clinical safety, drug efficacy, manufacturing, stability, bioequivalence or any other issues from a prior complete response letter (see story).

Remoxy ER has a “thick, sticky, high-viscosity capsule formulation designed to deter unapproved routes of drug administration, such as injection, snorting or smoking,” Pain Therapeutics says. It was developed to make oxycodone difficult to abuse yet provide 12 hours of steady pain relief when used as prescribed.

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