Ranbaxy Laboratories has filed a federal lawsuit trying to reverse the FDA's decision to cancel its approvals to make generics of AstraZeneca's blockbuster Nexium and Roche's Valcyte.
After months of percolating discontent about generic drug price hikes, the U.S. Senate is hauling drugmakers to a hearing this week. But the real threat lies at the Department of Justice, which is likely considering criminal prosecution for price-fixing and other antitrust violations, Law.com reports.
The FDA's new due diligence on generic drugs now has one victim: Mallinckrodt, which makes a knockoff version of Johnson & Johnson's ADHD drug Concerta. The Dublin-based drugmaker says the FDA is questioning whether its generic actually measures up to the brand.
Endo Health Solutions tried hard to ward off generic competitors for its big-selling pain med Opana ER. For instance, it petitioned the FDA to block competitors on safety grounds. According to a new lawsuit, Endo also paid off generics maker--and potential rival--Impax Laboratories.
Pfizer and Ranbaxy Laboratories persuaded a U.S. judge to toss out an antitrust lawsuit accusing them of conspiring to delay generic versions of the cholesterol-fighting blockbuster Lipitor.
Cheap Sovaldi is on the way, and it could very well be coming to an emerging market near you. Gilead has ironed out a licensing deal for the hep C wonder with 7 companies--including Mylan and Ranbaxy--and they'll bring low-cost copies to 91 developing countries.
How much, exactly, do generic drugs save in U.S. healthcare costs? It's a figure that's been growing over the past decade, and 2013 was no exception, a new report says.
Hospira's reprieve from generic Precedex competition was short-lived. The U.S. district court that temporarily stopped Precedex generics has now decided to let the copycats roll. And that could mean Hospira will soon be sharpening its job-cutting ax.
Glaxo, say hello to another Advair rival in Germany and Sweden. Monday, Indian generics maker Cipla rolled out its copy of GSK's respiratory behemoth in the two European countries, and the company's CEO says more are on the way.
After trying nearly everything in its power to protect lead product Copaxone from early generic competition, Teva just received some news it least wants to hear: Copycats are going after its new, long-acting version of the drug, too.