Drugs

Appeals Court Rules for FDA in Generic Fusilev Approval

The DC Circuit Court of Appeals has upheld a lower court ruling that found FDA was correct in approving a Sandoz ANDA for a generic copy of Spectrum Pharmaceuticals’ Fusilev (levoleucovorin) despite orphan drug exclusivity on a use for which Sandoz had not sought approval. Pursuant to FDA regulations, Sandoz’s label contains only methotrexate indications and makes no mention of the orphan-protected colorectal cancer indication. Spectrum had argued that because Sandoz markets its generic in vials that best suit dosing used for the colorectal cancer indication, FDA should not have approved the product because it will clearly be used for the protected indication.

FDA dismissed the claims about how the dosing vials were being marketed and argued that it only needed to examine the use indicated in Sandoz’s ANDA to make certain the generic drug “will not trench on the prior grant of exclusivity to Spectrum.” The appeals court agreed with the agency and found its interpretation of the Orphan Drug Act reasonable. “We ... conclude that during the approval process, the agency can look solely to Sandoz’s labeling claims to determine the intended use of its drug,” the judges wrote. “FDA’s approach here is consistent with how the agency has interpreted ‘intended use’ outside of the ANDA approval context to mean ‘the objective intent of the persons legally responsible for the labeling of drugs.’”

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