Drugs

FDA Approves Multiple ‘First’ Generics of Lilly’s Strattera

FDA has approved multiple drug manufacturers’ ANDAs for the first generic versions of Eli Lilly’s Strattera (atomoxetine) for treating attention-deficit/hyperactivity disorder in pediatric and adult patients. Approvals were granted to Apotex, Teva Pharmaceuticals USA, Aurobindo Pharma Limited and Glenmark Pharmaceuticals Limited for multiple strengths of the drug product. “Quickly bringing generics to market so patients have more options to treat their conditions is a top priority for the FDA,” CDER Office of Generic Drugs director Kathleen Uhl is quoted in a release as saying.

FDA says that atomoxetine must be dispensed with a patient Medication Guide that describes its uses and warnings. The drug also carries a boxed warning on an increased risk of suicidal ideation in children and adolescents. “Patients taking this medication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes,” it says. “Other important warnings include the risk of severe liver damage and potential for serious cardiovascular events.”

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