FDA Policy/General

Product Approval Summaries

DEVICES

FDA has approved Bausch + Lomb’s Ultra contact lenses for extended wear for up to six nights and seven days of continuous wear. The contact lenses include the company’s MoistureSeal technology, a patented combination of material and manufacturing process that helps to maintain 95% of lens moisture for 16 hours, according to the company. The device also features polyvinylpyrrolidone for enhanced wettability, a high oxygen transmissibility level, and a low modulus (i.e. the degree of a contact lens material's flexibility or its resistance to being deformed), Bausch + Lomb adds.

FDA has approved a Medtronic PMA for its Deep Brain Stimulation (DBS) therapy as adjunctive treatment for reducing the frequency of partial-onset seizures, in individuals 18 years of age or older who are refractory to three or more antiepileptic medications. “DBS therapy for epilepsy delivers controlled electrical pulses to a target in the brain called the anterior nucleus of the thalamus (ANT), which is part of a network involved in seizures,” the company says.

DRUGS

FDA has approved a Novartis NDA for Tafinlar (dabrafenib) and Mekinist (trametinib) for the combination treatment of anaplastic thyroid cancer that cannot be removed by surgery or has spread to other parts of the body. The approval covers the drugs’ use in patients that have a type of abnormal gene, BRAF V600E.

FDA has approved a Novartis NDA for Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, and involvement of lymph nodes, following complete resection. Approval was based on data from COMBI-AD, a Phase 3 study of 870 patients with Stage 3 BRAF V600E/K mutation-positive melanoma. “After a median follow-up of 2.8 years, the primary endpoint of relapse-free survival (RFS) was met,” the company says.

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