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The FDA has cited Actavis Totowa for deficiencies with its quality control unit, including a failure to investigate out-of-specification test results and to record all data.
Domestic pharmaceutical sales in January were approximately 8 percent higher than in the same period a year earlier, but the growth rate has slowed in recent months, according to an IMS Health report.
Sen. Chuck Grassley (R-Iowa) said comments from FDA Commissioner Andrew von Eschenbach discourage openness within the agency and raise questions about what problems the agency might be trying to conceal.
The U.S. Court of Appeals for the District of Columbia recently heard arguments in a landmark case to decide if terminally ill patients have a constitutional right to use drugs that have not been fully approved by the FDA.
The FDA has released a final guidance detailing new and current programs that convey drug safety information to the public as part of a larger drug safety initiative, the agency announced.
Consumers Union is calling for changes to strengthen S.484, the "Enhancing Drug Safety and Innovation Act," because the current version will not make a major difference in the FDA's drug safety processes, the organization said.
A federal court has blocked plans by Mylan Laboratories to launch amlodipine besylate, a generic version of Pfizer's blockbuster drug Norvasc, during the drug's pediatric exclusivity period.
Amgen reported a net income of $2.95 billion on revenue of $14.27 billion in 2006, compared with a net income of $3.67 billion on revenue of $12.43 billion in 2005.
The FDA got off to a slow start with new drug application (NDA) approvals in 2007, approving barely more than half as many as it had by this time last year.
Separate earnings reports released by Barr and Watson show expenses and other charges related to acquisition activity were key factors that drove earnings downward for both companies in 2006.