Drugs

Mifeprex Expanded Label Approved by FDA

FDA has approved a supplemental NDA for Danco Laboratories’ abortifacient Mifeprex (mifepristone) to relax label requirements for administering the drug. The approval expands on-label usage to 70 days after a woman’s last menstrual period. Previously, the label recommended the drug be used within 49 days of the last period. It also cuts the recommended number of doctor visits for the procedure from three to two. And the supplement reduced the dosage for the drug from 600 milligrams to 200 milligrams.

The American Congress of Obstetricians and Gynecologists (ACOG) supported the move. ACOG said in a statement that it was pleased that the updated regimen “reflects the current available scientific evidence and best practices, and includes many of the recommendations that ACOG had presented to the agency.”

Of course, any expanded labeling for Mifeprex has its controversy. Operation Rescue expressed its concern that “FDA has capitulated to pro-abortion demands and altered the approved use of Mifeprex, (also known as Mifepristone or RU486), to come in line with off-label protocols used by Planned Parenthood and other abortion businesses... Extending the upper recommended gestational limit from 49 to 70 days only ensures that the risk of an incomplete abortion will be multiplied, as will the number of women visiting emergency rooms around the country suffering from partial or failed abortions.”

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

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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