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Beleaguered Indian generics maker Wockhardt said Tuesday it will recall all remaining batches of 12 to 15 products from the U.S. that were manufactured at its Waluj and Chikalthana, India, plants, due to quality concerns. Read More
Particulates continue to be a major cause of recalled injectables, with Mylan late last month recalling eight lots of four drugs after foreign matter was found during quality control tests. Read More
Baxter International has issued its sixth recall of intravenous solutions since December 2013, recalling 15 lots — about 237,000 units — because they may contain particulate matter. Read More
AstraZeneca’s acid-reflux drug Nexium was the highest-costing drug prescribed under Medicare Part D in 2013, totaling $2.5 billion, according to new data released by the Centers for Medicare & Medicaid Services. Read More
A federal judge has ruled that the FDA was right in approving generic versions of Otsuka’s blockbuster antipsychotic Abilify, despite exclusivity remaining on at least one indication, removing any final obstacles to market entry of those drugs. Read More
The U.S. Attorney’s office filed documents Monday challenging Allergan’s efforts to suppress evidence that it submitted false claims related to its blockbuster ophthalmic drug Restasis. Read More
Takeda said Wednesday it will pay up to $2.4 billion to settle the majority of U.S. lawsuits involving its diabetes drug Actos, which has been linked to cancer. Read More
Particulates continue to be a major cause of recalled injectables, with Mylan on April 23 recalling eight lots of four drugs after foreign matter was found during quality control tests. Read More
Nearly three years after generics giant Mylan accused Warner Chilcott and Mayne Pharmaceuticals of “product hopping” with their acne medication Doryx, a federal judge has dismissed the case, ruling in favor of the brandmakers. Read More
The Federal Trade Commission can pursue billions of dollars in repayments from Cephalon over alleged pay-for-delay tactics to stall the marketing of a generic version of Provigil, the brandmaker’s narcolepsy drug. Read More