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The FDA is asking Acura Pharmaceuticals to conduct an additional study to prove its abuse-deterrent painkiller can actually deter abuse, throwing a wrench into the small drugmaker’s plans for approval. Read More
Roche got the greenlight on Thursday to market its blockbuster cancer drug Avastin for the treatment of advanced cervical cancer, making it the first biologic drug approved in combination with chemotherapy for the disease. Read More
Alabama’s Supreme Court Friday reaffirmed its ruling that a brand drugmaker can be held liable for damages caused by a generic version of its product if the generic carries warning labels that are drafted by the brand company. Read More
The FDA has been asked to turn over a trove of information related to the development of its proposed generic drug labeling rule, with GOP leaders of a key House investigative committee claiming the agency engaged in “dubious” behaviors in the rulemaking process. Read More
Companies exporting drugs from India were supposed to include barcodes featuring identification codes and serial numbers on all primary-level packaging by July 1, but the union government has postponed that date indefinitely. Read More
The FDA delivered its fifth warning letter to a compounding pharmacy in roughly two weeks, admonishing a Texas compounder for poor aseptic processing of sterile drugs. Read More
Cubist Pharmaceuticals recalled 101 lots of its antibiotic Cubicin because of a long-standing supplier issue that could have resulted in glass particles in vials. Read More
A New Jersey drug coating company hasn’t paid its generic drug facilities fees for the last two fiscal years, making every product it helps to manufacture automatically mislabeled, the FDA warned. Read More
Injectables giant Hospira has initiated its second nationwide recall in as many months due to a glass supplier issue that resulted in the presence of particulates. Read More
Impax received its second Form 483 in less than a week for a poor inspection of its U.S. manufacturing facility, igniting fresh doubts on the company’s plan to win approval of its Parkinson’s drug Rytary. Read More