Drugs

FDA Approves New OTC Primatene Mist

FDA has approved a new over-the-counter (OTC) version of Primatene Mist, a metered-dose inhaler indicated for providing temporary relief of symptoms of mild intermittent asthma. An earlier OTC version of the drug was withdrawn from the market in 2011 because it contained chlorofluorocarbon propellants, which are known to deplete the ozone layer. A statement issued by FDA commissioner Scott Gottlieb and CDER director Janet Woodcock says the new version contains hydrofluoroalkane propellants that are permitted under current international and U.S. law. Prescription inhalers that have different active ingredients also use those propellants, they said.

The statement says the scientific information reviewed to approve the new OTC version “shows there is a narrow population of those diagnosed with asthma that may benefit from having access to this type of OTC asthma inhaler. But the product has certain cautions.”

Gottlieb and Woodcock stress the need for all asthma patients to be under the care of a healthcare professional and that steps be taken to use Primatene Mist properly if it is determined to be suitable for a specific patient.

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