Drugs

Sandoz $195 Million Fine in Price Fixing Scheme

Sandoz has agreed to pay a $195 million criminal penalty under a deferred prosecution agreement in an ongoing generic drug price-fixing investigation. A four-count felony charge was filed 3/2 in the U.S. District Court for the Eastern District of Pennsylvania, charging Sandoz with participating in four criminal antitrust conspiracies, each with a competing manufacturer of generic drugs and various individuals, according to a Justice Department release. This represents the third pharmaceutical company to admit to criminal antitrust charges in the Antitrust Division’s ongoing investigation. The alleged conspiracies took place between 2013 and 2015.

Under the agreement, Sandoz has agreed to cooperate fully with the government Antitrust Division’s ongoing criminal investigation. In the filing, Sandoz admitted that it participated in the charged antitrust conspiracies, as follows:

Count one charges Sandoz for its role in a conspiracy involving clobetasol (cream, emollient cream, gel, ointment, and solution), desonide ointment, and nystatin triamcinolone cream.
Count two charges Sandoz for its role in a conspiracy with Kavod Pharmaceuticals (formerly known as Rising Pharmaceuticals) to allocate customers and fix prices of benazepril HCTZ. Rising was charged and entered into a deferred prosecution agreement 12/19.
Count three charges Sandoz for its role in a conspiracy that included desonide ointment.
Count four charges Sandoz for its role in a conspiracy that included tobramycin inhalation solution.

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