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Health Canada has expanded its initial import ban on Apotex’s finished product facility in Bangalore, India, to include the generics makers’ raw materials plant in the city, as well as other India manufacturers. Read More
The FDA issued a warning letter to injectables giant Hospira after an investigation of its Victoria, Australia, plant uncovered significant good manufacturing practice violations, including a failure to adequately investigate failed batches and determine levels of impurities in distributed products. Read More
Actavis said it will continue marketing the original formulation of its blockbuster Alzheimer’s drug Namenda for 60 days longer than originally planned, as the drugmaker faces antitrust allegations over its plans to withdraw the product in favor of a newer version. Read More
Impax has agreed to pay shareholders $8 million to end a class action lawsuit alleging the brand and generics maker deliberately withheld the extent of its manufacturing practice violation problems. Read More
A federal judge has tossed out some conspiracy claims brought against Abbott and its spinoff AbbVie over an alleged coupon scheme to boost sales of their branded arthritis drug Humira and testosterone therapy AndroGel. Read More
The FDA expects to have standardized formats for ANDA data submissions in place and required for all filers by the first half of fiscal year 2017. Read More
Better postmarket surveillance of generic drugs and a greater understanding of the bioequivalence of hard-to-compare products will top the FDA’s regulatory science priorities under GDUFA in the new fiscal year, the agency said. Read More
Pfizer and Ranbaxy have asked a federal judge to follow his own precedent and dismiss all remaining class-action lawsuits alleging the companies colluded to delay generic versions of Pfizer’s blockbuster cholesterol drug Lipitor. Read More
Canadian regulators plan to ratchet up scrutiny of patent litigation settlements between brand and generic drugmakers in search of antitrust deals that delay generic competition. Read More
FDA officials sought to clear up questions about what standards the agency will apply when approving biosimilars, emphasizing that manufacturers must prove their products are “highly similar” to the reference product in order to win a green light. Read More
The FDA late Tuesday unveiled a broad plan that will change the way it inspects drugmakers, approves recalls, issues and reviews enforcement decisions, screens imports and tests products for quality, with drugmakers likely to start feeling the impact by the end of 2015. Read More