Devices

FTC Approves Final Valeant Order

The Federal Trade Commission (FTC) has approved a final order settling charges that Valeant Pharmaceuticals International, the parent company of Bausch & Lomb, illegally acquired Paragon Holdings, a producer of polymer discs used in making rigid gas permeable contact lenses. The commission alleged that Valeant’s 2015 acquisition of Paragon eliminated competition between the two companies for the sale of FDA-approved discs for three types of gas permeable lenses. FTC also alleged that following the acquisition, Valeant used its market power to increase price, reduce volume discounts, decrease innovation, and reduce product distribution options in each disc market.

The order requires Valeant to sell Paragon in its entirety to a newly created entity, Paragon Companies, which also would acquire the assets of Pelican Products, a contact lens packaging manufacturer that Valeant acquired after it bought Paragon. Pelican was the only producer of FDA-approved vials used to ship some finished gas permeable lenses.

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