Drugs

FDA Prioritizing Review of ANDAs to Treat Opioid Overdose

Under a 2017 CDER Manual of Policies and Procedures (MAPP), Prioritization of the Review of Original Abbreviated New Drug Applications (ANDAs), Amendments, and Supplements, ANDA submissions for drug products indicated for the emergency treatment of known or suspected opioid overdose are eligible for priority review. FDA says that based on an HHS public health emergency declaration related to the opioid crisis, the agency has invoked the “Public Health Emergency” factor in the MAPP to expedite review of all ANDAs that reference NDAs for drugs indicated for the emergency treatment of known or suspected opioid overdose. FDA says it will continue to prioritize the reviews while the public health emergency exists.

An agency online announcement says there are five NDAs for three reference-listed drugs indicated for emergency treatment of known or suspected opioid overdose — Narcan (naloxone HCl) injection and nasal spray, Evzio (naloxone HCl) auto-injectors, and Revex (naloxone HCl) injection.

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