Drugs

Apotex Pays $24 Million in Price Fixing Scheme

Apotex has agreed to pay a $24.1 million criminal penalty and admit that it conspired with other generic drug sellers to artificially raise the price of pravastatin, a cholesterol-lowering drug that lowers the risk of heart disease and stroke. According to the one-count felony charge filed in the U.S. District Court for the Eastern District of Pennsylvania, Apotex and other generic drug companies agreed to increase and maintain the price of pravastatin from 5/2013 through 12/2015, according to a Justice Department release. The government also announced a deferred prosecution agreement resolving the charge against Apotex, which agreed to cooperate fully with the ongoing criminal investigation.

Apotex is the fourth company to be charged in connection with antitrust violations in the generic pharmaceutical industry. In March, Sandoz agreed to pay a $195 million criminal penalty under a deferred prosecution agreement (see earlier story). In 12/2019, Rising Pharmaceuticals agreed to pay over $3 million for conspiring to fix prices for benazepril HCTZ (see story). And in 6/2019 Heritage Pharmaceuticals agreed to pay over $7 million over price fixing related to diabetes drug glyburide (see story).

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