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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
Two U.S. senators are renewing efforts to crack down on pay-for-delay pharmaceutical deals, reintroducing the Preserve Access to Affordable Generics Act on Sept. 9. Read More
The FDA is clarifying when drugmakers can seek dispute resolution above the divisional level, citing five regulatory actions that are appropriate for a formal dispute resolution request. Read More
Despite industry concerns that ICH’s proposed new limits on metals are too strict, the organization released final guidance on elemental impurities in finished drugs that appears little changed from an earlier draft. Read More
The China State Council is calling for sweeping reforms of the country’s drug regulatory system, including specified timelines for deciding applications and increased public access to applications and information. Read More
Leaders of the House Energy & Commerce Committee are asking FDA Acting Commissioner Stephen Ostroff to explain what steps the agency is taking to address safety concerns around the blood thinner warfarin and its reference product, Coumadin. 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
Drug and biologics makers are urging the Centers for Medicare & Medicaid Services to reimburse each noninterchangeable biosimilar based on its own average sale price, saying that would avoid prescribing mix-ups and possible harm to patient care. Read More
Yet another Indian drugmaker has been dinged for serious data integrity and GMP issues — this time during a June 4 to 7 inspection by the World Health Organization. Read More