We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Amneal Pharmaceuticals can begin marketing its generics version of Allergan’s Alzheimer’s extended-release drug Namenda XR on Jan. 31, 2020, pending FDA approval, under an agreement reached by the two firms. Read More
Impax Laboratories says the FDA has inspected its Hayward, Calif. manufacturing plant and cleared it of all issues raised in a 2011 warning letter, paving the way for the launch of new drug products. Read More
Concordia Healthcare is acquiring UK-based Amdipharm Mercury for $3.5 billion, in a deal that greatly expands the Canadian drugmaker’s generic portfolio and global reach. Read More
With the last legal hurdle removed, Sandoz wasted no time launching its Zarxio biosimilar of Amgen’s chemotherapy product Neupogen nationwide — offering the first U.S. biosimilar at 15 percent below the price of its reference product. Read More
The FDA has banned imports of drugs made at Mumbai-India based Polydrug Laboratories, marking the latest development in ongoing issues involving Indian manufacturers. Read More
The GPhA is challenging the legality of the FDA’s final guidance calling for generics makers to design tablets and capsules to be similar in size and shape to their reference drug to ensure patient acceptance. Read More
Early notice of production shutdowns by manufacturers of life-supporting and life-sustaining drugs and biologics have allowed the FDA to avert more than 550 potential drug shortages in the last three years, the agency says in a final rule mandating early notice. Read More