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An FDA advisory committee voted on Tuesday to support withdrawal of FDA approval for AMAG Pharmaceuticals’ preterm birth injection Makena (hydroxyprogesterone caproate). Read More
Sunrider Manufacturing of Torrance, California drew a Form 483 from the FDA for incomplete complaint investigations and data integrity violations at its OTC manufacturing facility. Read More
Novartis hit three generic drugmakers with a lawsuit in a Delaware federal court for patent infringement over its heart-failure drug Entresto (sacubitril/valsartan). Read More
Allergan announced that its subsidiary Forest Laboratories will pay $750 million to direct purchasers to settle allegations of anticompetitive behavior over the Alzheimer’s drug Namenda (memantine). Read More
Sponsors of CDER-led drug-device combination products that include electronics or software should include specific technical information in their Type V drug master files, the FDA said in a draft guidance released on Monday. Read More