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The FDA received legal papers late Wednesday from generic firm Apotex regarding the agency’s decision to grant 180 days of market exclusivity for a version of Pfizer’s epilepsy drug Neurontin (gabapentin) to one generic firm, said FDA Chief Counsel Dan Troy yesterday during the Food and Drug Law Institute’s annual conference in Washington, D.C.
The FDA’s final rule banning dietary supplements containing ephedra due to safety concerns went into effect yesterday despite last-minute legal maneuvering by two manufacturers.
Mylan Laboratories apparently has finally escaped from its roller coaster ride in the multidistrict average wholesale price (AWP) litigation pending in a federal court in Massachusetts, the company announced yesterday.
Generic drugmaker Teva Pharmaceuticals has picked up another major ally in its bid to convince a federal district court to hear its patent challenge against Pfizer’s lucrative antidepressant Zoloft (sertraline HCl).
Dental care drugmaker CollaGenex Pharmaceuticals and generic firm Mutual Pharmaceuticals have settled a patent infringement suit over CollaGenex’s gum disease drug Periostat.
An argument by Novartis that the physiological interaction between a competitor’s cyclosporine product and a patient’s body infringed on one of its patents has been rejected by a federal appeals court.
The FTC is urging a federal appeals court to reverse a lower court’s dismissal of generic firm Teva Pharmaceutical’s filing challenging the validity of Pfizer’s patent for the antidepressant Zoloft (sertraline HCl) in a case that could clarify the controversial declaratory judgment provision of last year’s drug patent law.
The powerful chairman of the Senate Finance Committee introduced legislation yesterday that would make it legal to import drugs from Canada. “Free trade principles argue for allowing importation of drugs from Canada and other countries as long as those drugs are safe,” said Sen. Chuck Grassley (R-Iowa).