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Ranbaxy is fighting to reclaim its first-filer generic exclusivity on AstraZeneca’s blockbuster heartburn drug Nexium with a lawsuit challenging the FDA’s recent decision to rescind tentative ANDA approval for the therapy over manufacturing violations. Read More
The FDA has proposed criteria for how an ANDA can receive an expedited review under the “first generic” review prioritization category, a move the agency hopes will ease industry confusion over the generic drug incentive. Read More
Generics firm Pliva has asked the U.S. Supreme Court to throw out a decision by Iowa’s highest court that potentially paves the way for the company and other generics makers to be held liable in failure-to-update-label claims. Read More
British generic drugmakers want branded generics to be exempt from any further price cuts on brand pharmaceuticals, arguing their products already deliver greater savings than what can be achieved from government intervention. Read More
The FDA has approved an expanded indication for Genzyme’s leukemia drug Lemtrada to treat relapsing multiple sclerosis, 11 months after it initially turned down the company’s sBLA due to safety concerns. Read More
Specialty and generic drug maker Actavis has agreed to buy botox manufacturer Allergan for $66 billion in a move analysts say could help transform Actavis into a major pharma giant. Read More
FDA investigators will be able to photograph most areas of a facility during an inspection, including product labels and visible contamination of materials, according to a final guidance issued last month. Read More