Drugs

Sublocade Priority Review for Expanded Labeling

FDA has granted a priority review for an Indivior prior approval supplement for Sublocade (buprenorphine) extended-release injection for treating moderate to severe opioid use disorder (OUD). The submission is seeking approval to expand treatment options under two proposed updates to the drug’s label, including:

Alternative Injection Sites: Expands from the current subcutaneous abdominal injection site to also include the thigh, buttock, and back of the upper arm subcutaneously for induction and maintenance.
Rapid Induction Protocol: Reduces treatment induction time from the current seven-day minimum on transmucosal buprenorphine (TM BUP) to a single dose of TM BUP with one-hour observation period to confirm tolerability. It also allows for a second 300 mg dose to be administered as early as one week after the initial 300 mg injection, if needed.

“These updates are expected to enhance the patient experience and expand treatment access especially for those patients who, similar to the study participants, have long-term opioid use including fentanyl,” the company says.

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