Drugs

FDA Denies PMRS Requested Stay of Roxybond Approval

FDA has denied a Pharmaceutical Manufacturing Research Services (PMRS) 5/11 petition to stay the effective date of the approval of Inspiron’s Roxybond (oxycodone hydrochloride) with labeling claims pertaining to chronic use and abuse deterrence until the agency issues substantive written responses to two earlier PMRS petitions. The denial letter says that while the PMRS 2/19/16 and 3/6 petitions address matters of general relevance to opioid products, neither presents a basis for FDA to stay the approval of Roxybond while it considers such issues.

Roxybond was approved 4/20 as the first immediate-release opioid with labeling describing abuse-deterrent properties.

In its response, FDA cites the three criteria for review of a petition for stay of action and explains how PMRS failed to demonstrate that it will otherwise suffer irreparable injury, failed to cite sound public policy grounds supporting a stay, and failed to demonstrate how the public health and other public health interests would be served by a stay.

“While we welcome your engagement and that of other stakeholders on this critical public health subject,” the letter tells PMRS, “we do not agree that the requested stay would be in the public interest….”

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