Drugs

Novartis Walks Away from Generic Advair

Novartis says it is abandoning its work to gain FDA approval for a generic copy of GlaxoSmithKline’s Advair Diskus (fluticasone propionate/salmeterol). The product is indicated for treating asthma in patients aged four years and older, in addition to providing maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease.

In the company’s just-posted annual report, Novartis says it recently decided to discontinue the generic Advair development program in the U.S., “following a recent review of data read-outs.” In 2018, FDA issued the company a complete response letter that asked for more data before approval conditions could be met.

Novartis’ decision to walk away from its generic Advair development likely demonstrates the difficulty companies are having in showing bioequivalence for proposed orally inhaled drug products. FDA rejected similar applications from Mylan 3/2017 and Hikma 5/2017. In 1/2019, Mylan won final approval for its generic Advair copy, Wixela Inhub.

Novartis said its operating results include an impairment of $442 million because of the write-down of “in-process research and development” related to the discontinuation of the generic Advair development program.

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