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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
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
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
Drugmakers want to know when changes to chemical, manufacturing and controls in NDAs, ANDAs and BLAs must be reported to the FDA, saying draft guidance lacks clear criteria and examples. Read More
EU biopharma groups have lodged a complaint with the European Commission opposing a French law that promotes off-label use of medicines, saying it puts cost ahead of patient safety. Read More
Drugmakers want to know when changes to chemical, manufacturing and controls in NDAs, ANDAs and BLAs must be reported to the U.S. Food and Drug Administration, saying draft guidance lacks clear criteria and examples. Read More